non-specialty pipeline 2013 to 2016

non-specialty pipeline 2013 to 2016
Product Name
(generic name)
(aclidinium bromide / formoterol)
(AHU-377 / valsartan)
(aleglitazar)
(ALK Ragweed Tablet; Ambrosia
artemisiifolia)
(amphetamine polistirex)
(anamorelin HCl)
(arbaclofen placarbil SR)
(aripiprazole)
(asfotase alfa)
Company(ies)
Therapeutic Class Product Type Route
Status Date and
Status Description
FDA Filing
Current
Status
Potential Indication(s)
Volume 7, Issue 5
Quarter 2, 2013
Forest Respiratory Agents New Formulation IN 2014-Q1
Phase III Chronic Obstructive Pulmonary Disease (COPD)
Novartis Cardiovascular Agents New Molecular Entity;
New Combination
Takeda Endocrine & Metabolic
Drugs
OR 2014
Phase III Heart Failure
FDA Filing
New Molecular Entity OR 2015
Phase III Risk Reduction of Cardiovascular Disease in High-Risk
Patients with Type 2 Diabetes Mellitus (DM)
FDA Filing
Merck; ALK-Abello Respiratory Agents Biologic OR 2014-Jan 11
PDUFA
Pending
Approval
Neos Therapeutics ADHD / Antinarcotic /
Antiobesity / Anorexic
Agents
Helsinn
Therapeutics
Endocrine & Metabolic
Drugs
New Formulation OR 2013-Oct 28 Pending
Approval
PDUFA
FDA Filing
Prevention of Allergies Caused by Ragweed Allergen, in
Particular Rhinoconjunctivitis
Attention Deficit Hyperactivity Disorder (ADHD)
New Molecular Entity OR 2014-Mid Phase III Treatment of Cachexia & Anorexia in Cancer Patients
XenoPort Neuromuscular Drugs New Formulation OR 2013-H2
Phase III Spasticity
FDA Filing
Alkermes CNS Drugs New Formulation IM 2013-Q4
Phase III Schizophrenia
Alexion Endocrine & Metabolic
Drugs
FDA Filing
New Molecular Entity SC 2014-H1
Phase III Hypophosphatasia (HPP)
FDA Filing
RxOutlook® presented by Catamaran Inc. Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative processes.
Data are compiled from both public and private sources. © 2013 Catamaran Inc. All rights reserved. Catamaran is a registered trademark of Catamaran Inc.
1

non-specialty pipeline 2013 to 2016
Product Name
(generic name)
(avibactam / ceftazidime)
(bardoxolone methyl)
(basal insulin analog)
(bazedoxifene / conjugated
estrogens)
(bevenopran)
(bitopertin)
(brinzolamide / brimonidine)
(budesonide)
(buprenorphine / naltrexone (high
dose, buccal (BEMA))
Company(ies)
Therapeutic Class Product Type Route
AstraZeneca; Forest Antiinfective Agents New Molecular Entity;
New Combination
Status Date and
Status Description
FDA Filing
Current
Status
Potential Indication(s)
Volume 7, Issue 5
Quarter 2, 2013
IV 2014-H2
Phase III Intra-Abdominal Infections; Urinary Tract Infections;
Pneumonia
Reata; Abbott Miscellaneous New Molecular Entity OR 2013-Late Phase III Diabetic Nephropathy; Chronic Kidney Disease
Eli Lilly; Boehringer
Ingelheim
Endocrine & Metabolic
Drugs
Ligand; Pfizer Endocrine & Metabolic
Drugs
FDA Filing
New Formulation SC 2014-H2
Phase III Type 1 and Type 2 Diabetes Mellitus (DM)
New Molecular Entity;
New Combination
FDA Filing
OR 2013-Oct 3 Pending
Approval
PDUFA
Treatment of Moderate-to-Severe Vasomotor Symptoms
(VMS) and Vulvar and Vaginal Atrophy (VVA) Associated with
Menopause, as well as the Prevention of Postmenopausal
Osteoporosis
Eli Lilly Gastrointestinal Agents New Molecular Entity UK 2015-Q2
FDA Filing
Phase III Opioid-Induced Constipation (OIC)
Roche CNS Drugs New Molecular Entity OR 2014-H1
Phase III Schizophrenia
FDA Filing
Alcon Ophthalmic Agents New Combination IO 2013-Apr Pending
Approval
PDUFA
FDA Filing
Open Angle Glaucoma; Ocular Hypertension
Salix Gastrointestinal Agents New Formulation RE 2013-Q3
Phase III Ulcerative Colitis (UC)
BioDelivery Misc.
Psychotherapeutic &
Neurological Agents
New Formulation OR 2013-Q2
Phase III Opioid Dependence
FDA Filing
RxOutlook® presented by Catamaran Inc. Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative processes.
Data are compiled from both public and private sources. © 2013 Catamaran Inc. All rights reserved. Catamaran is a registered trademark of Catamaran Inc.
2

non-specialty pipeline 2013 to 2016
Product Name
(generic name)
(canagliflozin / metformin IR)
(cangrelor)
(cariprazine)
Company(ies)
Janssen Endocrine & Metabolic
Drugs
The Medicines
Company;
AstraZeneca
Forest; Gedeon
Richter
Therapeutic Class Product Type Route
Status Date and
Status Description
PDUFA
Current
Status
New Combination OR 2013-Oct 12 or Pending
Dec 12
Approval
Potential Indication(s)
Type 2 Diabetes Mellitus (DM)
Volume 7, Issue 5
Quarter 2, 2013
Hematological Agents New Molecular Entity IV 2013-Q2
FDA Filing
Phase III Prevention of Cardiac Ischemic Complications in Patients
with Acute Coronary Syndrome (ACS) Undergoing
Percutaneous Coronary Intervention (PCI)
CNS Drugs New Molecular Entity OR 2013-Sep 28 or Pending
Nov 28
Approval
PDUFA
Schizophrenia; Acute Treatment of Manic or Mixed Episodes
Associated with Bipolar I Disorder
(ceftolozane sulfate / tazobactam) Cubist Antiinfective Agents New Indication IV 2014-H2
FDA Filing
Phase III Hospital-Acquired (Nosocomial) Pneumonia (HAP)/Ventilator-
Associated Bacterial Pneumonia (VABP)
(ceftolozane sulfate / tazobactam)
(clopidogrel)
(dapagliflozin / metformin)
(desmoteplase)
(dexamethasone)
Cubist Antiinfective Agents New Molecular Entity;
New Combination
The Medicines
Company
AstraZeneca;
Bristol Myers Squibb
IV 2013-Late Phase III Complicated Urinary Tract Infections (cUTI) and Complicated
Intra-Abdominal Infections (cIAI)
FDA Filing
Hematological Agents New Formulation IV 2013
FDA Filing
Phase III Cardiovascular Disease in Acute Care Settings and
Atherothrombosis
Endocrine & Metabolic
Drugs
New Formulation OR 2013-H1
Phase III Type 2 Diabetes Mellitus (DM)
FDA Filing
PAION; Lundbeck Hematological Agents New Molecular Entity IV 2014-H1
Phase III Acute Ischemic Stroke
FDA Filing
Icon Bioscience Ophthalmic Agents New Formulation IO 2013-Early Phase III Treatment of Inflammation Associated with Cataract Surgery
FDA Filing
RxOutlook® presented by Catamaran Inc. Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative processes.
Data are compiled from both public and private sources. © 2013 Catamaran Inc. All rights reserved. Catamaran is a registered trademark of Catamaran Inc.
3

non-specialty pipeline 2013 to 2016
Product Name
(generic name)
(dexamethasone)
(dextroamphetamine)
(diclofenac nano-formulated)
(dulaglutide)
(dutogliptin)
(ecopipam HCl)
(edivoxetine)
(efinaconazole)
(elagolix)
Company(ies)
Therapeutic Class Product Type Route
Status Date and
Status Description
FDA Filing
Current
Status
Potential Indication(s)
EyeGate Ophthalmic Agents New Formulation IO 2013
Phase III Dry Eye; Uveitis
KemPharm;
MonoSol Rx
ADHD / Antinarcotic /
Antiobesity / Anorexic
Agents
Iroko Analgesics &
Anesthetics
Eli Lilly Endocrine & Metabolic
Drugs
Phenomix Endocrine & Metabolic
Drugs
FDA Filing
Volume 7, Issue 5
Quarter 2, 2013
New Formulation OR 2013-H1
Phase III Attention Deficit Hyperactivity Disorder (ADHD)
New Formulation OR 2013-Q4
Pending
Approval
PDUFA
FDA Filing
Treatment of Mild to Moderate Acute Pain in Adults
New Molecular Entity SC 2013
Phase III Type 2 Diabetes Mellitus (DM)
New Molecular Entity OR 2013
Phase III Type 2 Diabetes Mellitus (DM)
FDA Filing
Psyadon CNS Drugs New Molecular Entity OR 2013
Phase III Lesch Nyhan disease (LND)
FDA Filing
Eli Lilly CNS Drugs New Molecular Entity OR 2013
Phase III Major Depressive Disorder (MDD); Attention Deficit
Hyperactivity Disorder (ADHD)
FDA Filing
Kaken; Valeant Antiinfective Agents New Molecular Entity EX 2013-May 26 Pending
Approval
Abbott; Neurocrine Endocrine & Metabolic
Drugs
PDUFA
New Molecular Entity OR 2016
Phase III Endometriosis
FDA Filing
Distal Lateral Subungal Onychomycosis
RxOutlook® presented by Catamaran Inc. Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative processes.
Data are compiled from both public and private sources. © 2013 Catamaran Inc. All rights reserved. Catamaran is a registered trademark of Catamaran Inc.
4

non-specialty pipeline 2013 to 2016
Product Name
(generic name)
(empagliflozin)
(ethinyl estradiol / levonorgestrel)
(etodolac / lidocaine)
(ferric iron complex)
(ferric trimaltol)
(flutemetamol)
(glufosfamide)
(glycopyrronium bromide /
indacaterol)
Company(ies)
Boehringer
Ingelheim; Eli Lilly
Therapeutic Class Product Type Route
Endocrine & Metabolic
Drugs
Agile Therapeutics Endocrine & Metabolic
Drugs
IL Pharma; Kowa Analgesics &
Anesthetics
Status Date and
Status Description
PDUFA
Current
Status
New Molecular Entity OR 2014-Jan 25 Pending
Approval
New Formulation TD 2013-H1
PDUFA
Pending
Approval
FDA Filing
Potential Indication(s)
Type 2 Diabetes Mellitus (DM)
Prevention of Pregnancy
Volume 7, Issue 5
Quarter 2, 2013
New Formulation TD 2013
Phase III Topical Patch for the Treatment of Pain & Inflammation
Shield Therapeutics Hematological Agents New Formulation OR 2013-H1
Phase III Iron Deficiency Anemia (IDA) Associated with Inflammatory
Bowel Disease (IBD)
FDA Filing
Vitra Hematological Agents New Formulation OR 2013-H1
Phase III Iron Deficiency Anemia (IDA) Associated with Inflammatory
Bowel Disease (IBD)
FDA Filing
GE Healthcare Diagnostic Products New Molecular Entity IV 2013-Nov 8 Pending
Approval
Eleison/Threshold
Pharmaceuticals
Antineoplastics &
Adjunctive Therapies
PDUFA
New Molecular Entity IV 2014-2015 Phase III Pancreatic Cancer
FDA Filing
FDA Filing
Use in the Visual Detection of Beta Amyloid in the Brains of
Adult Patients with Cognitive Impairment who are Being
Evaluated for Alzheimer’s Disease (AD) or Other Cognitive
Disorders
Novartis Respiratory Agents New Combination IN 2014-Late Phase III Moderate to Severe Chronic Obstructive Pulmonary Disease
(COPD)
RxOutlook® presented by Catamaran Inc. Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative processes.
Data are compiled from both public and private sources. © 2013 Catamaran Inc. All rights reserved. Catamaran is a registered trademark of Catamaran Inc.
5

non-specialty pipeline 2013 to 2016
Product Name
(generic name)
(granisetron sustained-release)
(herpes zoster vaccine)
(Human papilloma virus vaccine)
(inactivated varicella zoster virus
vaccine)
(inactivated varicella zoster virus
vaccine)
(insulin glargine)
(insulin peglispro)
(isavuconazonium chloride)
(ketoprofen / amitriptyline /
oxymetazoline)
Company(ies)
Therapeutic Class Product Type Route
Status Date and
Status Description
PDUFA
Current
Status
AP Pharma Gastrointestinal Agents New Formulation SC 2014-H1
Complete
Response
Letter
Potential Indication(s)
Volume 7, Issue 5
Quarter 2, 2013
Prevention of Acute- and Delayed-Onset Chemotherapy-
Induced Nausea & Vomiting (CINV)
GlaxoSmithKline Biologicals New Formulation IV 2014
FDA Filing
Phase III Prevention of Varicella zoster Infection (Shingles) in the
Elderly
Merck Biologicals New Formulation IM 2013
Phase III Prevention of Genital Warts & Cervical Cancer Caused by
Human Papillomavirus (HPV) Infection
FDA Filing
Merck Biologicals New Indication SC 2015-2016
FDA Filing
Phase III Prevention of Herpes Zoster (HZ) Infection and HZ-Related
Complications in Patients with Cancer
Merck Biologicals Vaccine SC 2014
Phase III Prevention of Herpes Zoster (HZ) Infection and HZ-Related
Complications in Hematopoietic Cell Transplant Patients
Eli Lilly; Boehringer
Ingelheim
Endocrine & Metabolic
Drugs
Eli Lilly Endocrine & Metabolic
Drugs
FDA Filing
New Formulation SC 2013
Phase III Type 1 & Type 2 Diabetes Mellitus (DM)
FDA Filing
New Formulation SC 2014
Phase III Type 1 and Type 2 Diabetes Mellitus (DM)
FDA Filing
Basilea; Astellas Antiinfective Agents New Molecular Entity IV 2013
Phase III Invasive Candidiasis
Omeros Analgesics &
Anesthetics
New Formulation; New
Combination
FDA Filing
EX 2013-H1
Phase III Irrigation Solution Formulation for Treatment of Pain and
Improvement of Joint Function Associated with Arthroscopy
FDA Filing
RxOutlook® presented by Catamaran Inc. Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative processes.
Data are compiled from both public and private sources. © 2013 Catamaran Inc. All rights reserved. Catamaran is a registered trademark of Catamaran Inc.
6

non-specialty pipeline 2013 to 2016
Product Name
(generic name)
(ketorolac / phenylephrine)
(lesinurad)
(levomilnacipran)
(lidocaine / prilocaine)
(liraglutide)
(mavoglurant)
(mavoglurant)
(naloxegol)
(naloxone)
(obeticholic acid)
Company(ies)
Therapeutic Class Product Type Route
Status Date and
Status Description
FDA Filing
Current
Status
Potential Indication(s)
Volume 7, Issue 5
Quarter 2, 2013
Omeros Ophthalmic Agents New Combination IO 2013-H1
Phase III Prevention of Miosis During Lens Replacement Surgery, and
the Reduction of Post-Operative Pain and Irritation
Ardea Biosciences;
AstraZeneca
Analgesics &
Anesthetics
New Molecular Entity OR 2014-H2
Phase III Hyperuricemia; Gout
FDA Filing
Forest CNS Drugs New Formulation OR 2013-Jul 27 Pending
Approval
Shionogi; Sciele Genitourinary Products New Formulation; New
Indication
Novo Nordisk Endocrine & Metabolic
Drugs
PDUFA
FDA Filing
Major Depressive Disorder (MDD)
EX 2013
Phase III Premature Ejaculation (PE)
New Indication SC 2013-2014 Phase III Obesity
FDA Filing
Novartis Neuromuscular Drugs New Molecular Entity OR 2014
Phase III Fragile X Syndrome
FDA Filing
Novartis Neuromuscular Drugs New Indication OR 2015
Phase III Parkinson's Disease L-Dopa Induced Dyskinesia
FDA Filing
AstraZeneca; Nektar Gastrointestinal Agents New Molecular Entity OR 2013-Q3
Phase III Opioid-Induced Constipation (OIC)
Lightlake
Therapeutics
FDA Filing
CNS Drugs New Formulation NA 2013-Q3 to 2014 Phase III Binge Eating Disorder
FDA Filing
Intercept Gastrointestinal Agents New Molecular Entity OR 2014-Mid Phase III Primary Biliary Cirrhosis (PBC); Hepatic Fibrosis
FDA Filing
RxOutlook® presented by Catamaran Inc. Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative processes.
Data are compiled from both public and private sources. © 2013 Catamaran Inc. All rights reserved. Catamaran is a registered trademark of Catamaran Inc.
7

non-specialty pipeline 2013 to 2016
Product Name
(generic name)
(odanacatib)
(olopatadine)
(omarigliptin)
(omeprazole immediate-release /
aspirin delayed-release)
(omeprazole immediate-release /
aspirin delayed-release)
(ondansetron)
(otamixaban)
(oxycodone extended-release)
(oxycodone)
Company(ies)
Merck; Celera Endocrine & Metabolic
Drugs
Therapeutic Class Product Type Route
Status Date and
Status Description
FDA Filing
Current
Status
Potential Indication(s)
Volume 7, Issue 5
Quarter 2, 2013
New Molecular Entity OR 2014
Phase III Treatment of Postmenopausal Osteoporosis
Alcon; Novartis Ophthalmic Agents New Formulation OP 2014
Phase III Ocular Allergy
Merck Endocrine & Metabolic
Drugs
FDA Filing
New Molecular Entity OR >2014
Phase III Type 2 Diabetes Mellitus
FDA Filing
Pozen Cardiovascular Agents New Combination OR 2014-Jan 27 Pending
Approval
PDUFA
Pozen Cardiovascular Agents New Combination OR 2014-Jan 27 Pending
Approval
PDUFA
FDA Filing
Secondary Prevention of Cardio - and Cerebrovascular
Events and to Reduce the Risk of Gastric Ulcers in Patients
at Risk of Aspirin Induced Gastric Ulcers (40 mg/325 mg)
Secondary Prevention of Cardio - and Cerebrovascular
Events and to Reduce the Risk of Gastric Ulcers in Patients
at Risk of Aspirin Induced Gastric Ulcers (40 mg/81 mg)
RedHill Biopharma Gastrointestinal Agents New Formulation OR 2013-Q4
Phase III Prevention of Nausea & Vomiting in Cancer Patients
Sanofi Hematological Agents New Molecular Entity IV 2013
Phase III Prevention of Coronary Complications in Patients with Acute
Coronary Syndrome (ACS)
Collegium Analgesics &
Anesthetics
Phosphagenics Analgesics &
Anesthetics
FDA Filing
New Formulation OR 2013-Late Phase III Moderate to Severe Chronic Pain
FDA Filing
New Formulation TD 2013
Phase III Moderate to Severe Pain
FDA Filing
RxOutlook® presented by Catamaran Inc. Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative processes.
Data are compiled from both public and private sources. © 2013 Catamaran Inc. All rights reserved. Catamaran is a registered trademark of Catamaran Inc.
8

non-specialty pipeline 2013 to 2016
Product Name
(generic name)
(ozenoxacin)
(palonosetron / netupitant)
(paroxetine mesylate)
(patiromer)
(pediatric hexavalent combination
vaccine)
Company(ies)
Therapeutic Class Product Type Route
Status Date and
Status Description
FDA Filing
Current
Status
Potential Indication(s)
Ferrer Antiinfective Agents New Molecular Entity EX 2015
Phase III Skin and Skin-Structure Infections
Helsinn; Eisai Gastrointestinal Agents New Combination; New
Molecular Entity
FDA Filing
Noven CNS Drugs New Indication OR 2013-Jun 28 Pending
Approval
Volume 7, Issue 5
Quarter 2, 2013
OR 2013-2014 Phase III Chemotherapy-Induced Nausea and Vomiting (CINV)
PDUFA
Treatment of Moderate to Severe Vasomotor Symptoms
Associated with Menopause
Relypsa Gastrointestinal Agents New Molecular Entity OR 2014-H1
FDA Filing
Phase III Treatment of Hyperkalemia in Patients with Chronic Kidney
Disease (CKD)
Merck Biologicals New Formulation IM 2014
Phase III Prevention of Hepatitis B Virus (HBV) Infection
FDA Filing
(PEGylated recombinant Factor VIII) Baxter Hematological Agents New Formulation IV 2014
FDA Filing
Phase II/III Hemophilia A
(peramivir)
(pimavanserin)
(pradigastat)
(preladenant)
BioCryst; Shionogi Antiinfective Agents New Molecular Entity IV 2013-H1
Phase III Treatment of Seasonal Influenza Virus Infections
FDA Filing
Acadia; Biovail Neuromuscular Drugs New Molecular Entity OR 2014-End Phase III Parkinson's Disease (PD) Psychosis
Novartis Endocrine & Metabolic
Drugs
FDA Filing
New Molecular Entity OR 2014
Phase III Familial Chylomicronemia Syndrome
FDA Filing
Merck Neuromuscular Drugs New Molecular Entity OR 2014
Phase III Parkinson's Disease (PD)
FDA Filing
RxOutlook® presented by Catamaran Inc. Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative processes.
Data are compiled from both public and private sources. © 2013 Catamaran Inc. All rights reserved. Catamaran is a registered trademark of Catamaran Inc.
9

non-specialty pipeline 2013 to 2016
Product Name
(generic name)
(ranirestat)
(rifamycin SV MMX)
(rizatriptan)
(rolapitant)
(safinamide)
(soluble ferric pyrophosphate)
(sufentanil nanotab)
(suvorexant)
(tasimelteon)
Company(ies)
Dainippon
Sumitomo Pharma;
Eisai
Therapeutic Class Product Type Route
Endocrine & Metabolic
Drugs
Status Date and
Status Description
FDA Filing
Current
Status
Potential Indication(s)
New Molecular Entity OR 2014
Phase III Diabetic Peripheral Neuropathy
Santarus Antiinfective Agents New Formulation OR 2013-Late Phase III Infectious Diarrhea
RedHill Biopharma;
IntelGenx
Analgesics &
Anesthetics
FDA Filing
New Formulation OR 2014-Jan 27 Pending
Approval
PDUFA
Treatment of Acute Migraine
Volume 7, Issue 5
Quarter 2, 2013
OPKO; Tesaro Gastrointestinal Agents New Molecular Entity OR 2013-H2
FDA Filing
Phase III Prevention of Chemotherapy-Induced Nausea and Vomiting
(CINV)
Newron; Merck
Serono
Neuromuscular Drugs New Molecular Entity OR 2013-H2
Phase III Parkinson's Disease (PD)
FDA Filing
Rockwell Medical Hematological Agents New Formulation IV 2013-Q4
Phase III Iron Deficiency Anemia in Hemodialysis Patients
AcelRx Analgesics &
Anesthetics
FDA Filing
New Formulation SL 2013-Q3
Phase III Post-Operative Pain
FDA Filing
Merck CNS Drugs New Molecular Entity OR 2013-Jun to Nov Pending
Approval
Vanda; Bristol
Myers Squibb
PDUFA
FDA Filing
Insomnia Characterized by Difficulties with Sleep Onset
and/or Maintenance
CNS Drugs New Molecular Entity OR 2013-Mid Phase III Insomnia; Circadian Rhythm Sleep Disorders (CRSDs); Non-
24 Hour Sleep/Wake Disorder (N24SWD)
RxOutlook® presented by Catamaran Inc. Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative processes.
Data are compiled from both public and private sources. © 2013 Catamaran Inc. All rights reserved. Catamaran is a registered trademark of Catamaran Inc.
10

non-specialty pipeline 2013 to 2016
Product Name
(generic name)
(tavaborole)
(tecovirimat)
(tedizolid phosphate)
(tolvaptan)
(umeclidinium)
(uridine triacetate)
(vilanterol)
(vorapaxar sulfate)
(zucapsaicin; cis-capsaicin)
Company(ies)
Therapeutic Class Product Type Route
Status Date and
Status Description
FDA Filing
Current
Status
Potential Indication(s)
Anacor Antiinfective Agents New Molecular Entity EX 2013-Mid Phase III Onychomycosis
SIGA Technologies;
ViroPharma
FDA Filing
Volume 7, Issue 5
Quarter 2, 2013
Antiinfective Agents New Molecular Entity OR 2013
Phase III Prevention & Treatment of Smallpox Infection
Trius Antiinfective Agents New Molecular Entity OR; IV 2013-H2
Phase III Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Otsuka Endocrine & Metabolic
Drugs
New Formulation; New
Indication
FDA Filing
OR 2013-Sep 1 Pending
Approval
PDUFA
Autosomal Dominant Polycystic Kidney Disease (ADPKD)
GlaxoSmithKline Respiratory Agents New Molecular Entity IN 2013
FDA Filing
Phase III Chronic Obstructive Pulmonary Disease (COPD); Asthma
BTG; Wellstat Antineoplastics &
Adjunctive Therapies
GlaxoSmithKline;
theravance
New Molecular Entity OR 2013-H2
Phase III Accidental Overexposure to the Chemotherapy Drug
Fluorouracil (5-FU) due to Dosing Errors or Impaired
Clearance of 5-FU from the Body
FDA Filing
Respiratory Agents New Molecular Entity IN 2013
Phase III Chronic Obstructive Pulmonary Disease (COPD)
FDA Filing
Merck Hematological Agents New Molecular Entity OR 2013
Phase III Prevention of Cardiovascular Events in Patients with a
History of Heart Attack and No History of Transient Ischemic
Attack (TIA) or Stroke
Winston Analgesics &
Anesthetics
FDA Filing
New Formulation EX 2013
PDUFA
Pending
Approval
Osteoarthritis
RxOutlook® presented by Catamaran Inc. Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative processes.
Data are compiled from both public and private sources. © 2013 Catamaran Inc. All rights reserved. Catamaran is a registered trademark of Catamaran Inc.
11

non-specialty pipeline 2013 to 2016
Product Name
(generic name)
ABT-719; AP-214; ZP-1480
AFREZZA (insulin human [rDNA
origin] inhalation powder)
AGGRASTAT (tirofiban HCl)
AL-60371
AMELUZ (5-aminolevulinic acid
nanocolloidal)
AMIKET (ketamine / amitriptyline)
AMITIZA (lubiprostone)
ANDROXAL (enclomiphene citrate)
Company(ies)
Therapeutic Class Product Type Route
Status Date and
Status Description
FDA Filing
Current
Status
Potential Indication(s)
Volume 7, Issue 5
Quarter 2, 2013
AbbVie Cardiovascular Agents New Molecular Entity IV 2014-Early Phase III Post-Surgical Kidney Injury Associated with Cardiac Surgery
MannKind Endocrine & Metabolic
Drugs
New Formulation IN 2013-Sep Complete
Response
Letter
FDA Re-Filing
Medicure Hematological Agents New Dosing IV 2013-Nov 8 Pending
Approval
PDUFA
Type 1 & Type 2 Diabetes Mellitus (DM)
Addition of a High Dose Bolus (HDB) Regimen (an initial
bolus of 25 mcg/kg and then continued at 0.15
mcg/kg/min) to the Approved Prescribing Information for
AGGRASTAT
Alcon Otic Agents New Molecular Entity OT 2013
FDA Filing
Phase III Acute Otitis Externa and Otitis Media with a Tympanostomy
Tube
Biofrontera Antineoplastics &
Adjunctive Therapies
EpiCept Analgesics &
Anesthetics
New Formulation EX 2013
Phase III Actinic Keratoses
FDA Filing
New Formulation EX 2014
FDA Filing
Phase III Neuropathic Pain Associated with Chemotherapy-Induced
Peripheral Neuropathy in Patients Previously Treated with
Taxane-Based Chemotherapy
Sucampo; Takeda Gastrointestinal Agents New Indication OR 2013-Apr 26 Pending
Approval
Repros Endocrine & Metabolic
Drugs
PDUFA
New Formulation OR 2014-Mid Phase III Secondary Hypogonadism
FDA Filing
RxOutlook® presented by Catamaran Inc. Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative processes.
Data are compiled from both public and private sources. © 2013 Catamaran Inc. All rights reserved. Catamaran is a registered trademark of Catamaran Inc.
Opioid-Induced Constipation (OIC) in Patients with Chronic,
Non-Cancer Pain
12

non-specialty pipeline 2013 to 2016
Product Name
(generic name)
ANOHEAL (diltiazem HCl)
ANORO ELLIPTA (umeclidinium
bromide / vilanterol)
ARIMENDA (memantine HCl ER /
donepezil HCl)
ASACARD (acetylsalicylic acid)
ATOZET (atorvastatin calcium /
ezetimibe)
AVEED (testosterone undecanoate)
BEMA LA (buprenorphine (buccal,
BEMA))
BERIPLEX (human 4-factor
prothrombin complex concentrate)
Company(ies)
Ventrus; SLA
Pharma
GlaxoSmithKline;
Theravance
Therapeutic Class Product Type Route
Analgesics &
Anesthetics
Adamas; Forest Misc.
Psychotherapeutic &
Neurological Agents
New Formulation; New
Indication
Respiratory Agents New Molecular Entity;
New Combination
Status Date and
Status Description
FDA Filing
Current
Status
Potential Indication(s)
EX 2013-Q4
Phase III Pain Associated with Anal Fissure
IN 2013-Dec 18 Pending
Approval
PDUFA
FDA Filing
Volume 7, Issue 5
Quarter 2, 2013
Long-Term Once-Daily Maintenance Bronchodilator
Treatment of Airflow Obstruction in Patients with Chronic
Obstructive Pulmonary Disease (COPD), including Chronic
Bronchitis and Emphysema
New Combination OR 2014
Phase III Treatment of Moderate to Severe Dementia of the
Alzheimer's Type
Flamel; NewHaven Cardiovascular Agents New Formulation OR 2013-May 31
PDUFA
Pending
Approval
Merck Cardiovascular Agents New Combination OR 2013-May to Jun Pending
Approval
Endo Endocrine & Metabolic
Drugs
BioDelivery; Endo Analgesics &
Anesthetics
PDUFA
New Formulation IM 2013-Q2
PDUFA
Pending
Approval
FDA Filing
Secondary Prevention of Cardiovascular Disease
Hypercholesterolemia; Dyslipidemia
Male Hypogonadism
New Formulation OR 2014-H2
Phase III Moderate to Severe Chronic Pain
CSL Behring Hematological Agents New Molecular Entity IV 2013-Mar 29
PDUFA
Pending
Approval
Urgent Reversal of Vitamin K-Antagonist Therapy (i.e.,
warfarin) in Patients with Acute Major Bleeding
RxOutlook® presented by Catamaran Inc. Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative processes.
Data are compiled from both public and private sources. © 2013 Catamaran Inc. All rights reserved. Catamaran is a registered trademark of Catamaran Inc.
13

non-specialty pipeline 2013 to 2016
Product Name
(generic name)
BEXSERO (4CMenB)
BREO ELLIPTA (fluticasone furoate
/ vilanterol trifenatate)
BRIDION (sugammadex)
BRILINTA (ticagrelor)
BRILINTA (ticagrelor)
BRINAVESS (vernakalant HCl)
BRINTELLIX (vortioxetine HCl)
Company(ies)
Therapeutic Class Product Type Route
Status Date and
Status Description
FDA Filing
Current
Status
Potential Indication(s)
Novartis Biologicals New Formulation IM 2014
Phase III Meningococcal Disease
GlaxoSmithKline;
Theravance
Respiratory Agents New Molecular Entity;
New Combination
IN 2013-May 12 Pending
Approval
PDUFA
Merck CNS Drugs New Molecular Entity IV 2013-H2
Pending
Approval
PDUFA
Volume 7, Issue 5
Quarter 2, 2013
Long-Term Once-Daily Maintenance Treatment of Airflow
Obstruction in Patients with Chronic Obstructive Pulmonary
Disease (COPD), including Chronic Bronchitis and/or
Emphysema and to Reduce Exacerbations of COPD in
Patients with a History of Exacerbations
Reversal of Neuromuscular Blockade
AstraZeneca Hematological Agents New Indication OR 2015
FDA Filing
Phase III Cardiovascular Outcomes Data Based on PEGASUS-TIMI
(e.g., Reduced Risk of Cardiovascular Events with Dual
Antiplatelet Therapy)
AstraZeneca Hematological Agents New Indication OR 2016
Phase III Cardiovascular Outcomes in Patients with Peripheral Artery
Disease (PAD)
FDA Filing
Cardiome Cardiovascular Agents New Molecular Entity IV 2013
FDA Re-Filing
Phase III Rapid Conversion of Recent Onset Atrial Fibrillation (AF) to
Sinus Rhythm in Non-Surgery Adult Patients with AF of 7
Days or Less and in Post-Cardiac Surgery Patients with AF of
3 days or Less
Lundbeck; Takeda CNS Drugs New Molecular Entity OR 2013-Oct 2 Pending
Approval
PDUFA
Major Depressive Disorder (MDD)
RxOutlook® presented by Catamaran Inc. Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative processes.
Data are compiled from both public and private sources. © 2013 Catamaran Inc. All rights reserved. Catamaran is a registered trademark of Catamaran Inc.
14

non-specialty pipeline 2013 to 2016
Product Name
(generic name)
BROMSITE (bromfenanc)
COMPLEOTRT (testosterone
intranasal)
CONTRAVE (naltrexone HCl ER /
bupropion HCl ER)
CONXN (serelaxin)
DEXASITE (dexamethasone)
DUODOPA (carbidopa / levodopa)
DUREZOL (difluprednate)
DUROMIST (sildenafil)
ENTEREG (alvimopan)
Company(ies)
Therapeutic Class Product Type Route
Status Date and
Status Description
FDA Filing
Current
Status
Potential Indication(s)
Volume 7, Issue 5
Quarter 2, 2013
InSite Vision Ophthalmic Agents New Formulation OP 2013
Phase III Pain, Swelling, and Inflammation Associated with Ocular
Surgery
Trimel Endocrine & Metabolic
Drugs
Orexigen; Takeda ADHD / Antinarcotic /
Antiobesity / Anorexic
Agents
New Formulation NA 2013-Q2
Phase III Male Hypogonadism
FDA Filing
New Combination OR 2013-H2
FDA Re-Filing
Complete
Response
Letter
Novartis Cardiovascular Agents New Molecular Entity IV 2013-Early Phase III Acute Decompensated Heart Failure
FDA Filing
FDA Filing
Obesity
InSite Vision Ophthalmic Agents New Formulation EX 2013
Phase III Blepharitis
AbbVie Neuromuscular Drugs New Formulation IG 2013-Sep or 2013- Pending
Oct
Approval
PDUFA
Alcon Ophthalmic Agents New Indication OP 2013-Aug
PDUFA
Pending
Approval
FDA Filing
Advanced Parkinson's Disease (PD)
NovaDel Cardiovascular Agents New Formulation OR 2013
Phase III Erectile Dysfunction (ED)
Cubist Gastrointestinal Agents New Indication OR 2013-Oct 21 Pending
Approval
RxOutlook® presented by Catamaran Inc. Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative processes.
Data are compiled from both public and private sources. © 2013 Catamaran Inc. All rights reserved. Catamaran is a registered trademark of Catamaran Inc.
PDUFA
Post Cataract Surgical Inflammation in Pediatric Patients
Accelerate GI Recovery Following Any Surgery that Includes a
Bowel Resection with Primary Anastomosis
15

non-specialty pipeline 2013 to 2016
Product Name
(generic name)
ESMYA (ulipristal acetate)
ESOMEZOL (esomeprazole
strontium)
EXPAREL (bupivacaine extendedrelease)
FERAHEME (ferumoxytol)
FLU Q-QIV (quadrivalent inactivated
split virion vaccine)
FLUZONE Quadrivalent (seasonal
influenza vaccine (quadrivalent))
FORXIGA (dapagliflozin)
FV-100
Company(ies)
Watson; Gedeon
Richter
Therapeutic Class Product Type Route
Endocrine & Metabolic
Drugs
New Formulation; New
Indication
Status Date and
Status Description
FDA Filing
Current
Status
Hanmi; Amneal Gastrointestinal Agents New Formulation OR 2013-Apr 29 Pending
Approval
Pacira Analgesics &
Anesthetics
Potential Indication(s)
Volume 7, Issue 5
Quarter 2, 2013
OR 2013-Mid Phase III Anemia Associated with Uterine Leiomyomas
PDUFA
FDA Filing
Gastric Ulcer
New Indication SC 2013-Late or 2014-
Early
Phase III Nerve Block
AMAG Hematological Agents New Indication IV 2013-Oct 21
PDUFA
Pending
Approval
GlaxoSmithKline Biologicals New Formulation IM 2013-Aug or Oct 23 Pending
Approval
PDUFA
Sanofi Pasteur Biologicals New Formulation IM 2013-Q2
Pending
Approval
AstraZeneca;
Bristol Myers Squibb
Endocrine & Metabolic
Drugs
PDUFA
New Molecular Entity OR 2013-Mid Complete
Response
Letter
FDA Re-Filing
Treatment of Iron Deficiency Anemia (IDA) in Adult Patients
who have Failed or Could not Tolerate Oral Iron Treatment
Prevention of Seasonal Influenza Virus Infection in Adults
and Children >/= 3 Years of Age
Active Immunization of Children and Adults 6 Months of Age
and Older for the Prevention of Influenza Disease Caused by
Influenza Virus Subtypes A and Types B Contained in the
Vaccine
Type 2 Diabetes Mellitus (DM)
Inhibitex Antiinfective Agents New Molecular Entity OR 2014-Early
FDA Filing
Phase III Varicella zoster Virus Infection; Herpes zoster
RxOutlook® presented by Catamaran Inc. Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative processes.
Data are compiled from both public and private sources. © 2013 Catamaran Inc. All rights reserved. Catamaran is a registered trademark of Catamaran Inc.
16

non-specialty pipeline 2013 to 2016
Product Name
(generic name)
FYCOMPA (perampanel)
FYCOMPA (perampanel)
GRAZAX; ALUTARD SQ (ALK Grass
Pollen Tablet; Phleum pratense)
HEPLISAV (hepatitis B virus vaccine
recombinant, adjuvanted)
ICLUSIG (ponatinib)
IDEGLIRA (insulin degludec /
liraglutide)
ILUVIEN (fluocinolone acetonide
extended-release)
IMPRACOR (ketoprofen)
INJECTAFER (ferric carboxymaltose)
Company(ies)
Therapeutic Class Product Type Route
Status Date and
Status Description
FDA Filing
Current
Status
Potential Indication(s)
Eisai Neuromuscular Drugs New Indication OR 2013-2014 Phase III Monotherapy of Partial Onset Seizures
Eisai Neuromuscular Drugs New Indication OR 2013
Phase III Generalized Tonic-Clonic Seizures
FDA Filing
Merck; ALK-Abello Respiratory Agents New Molecular Entity OR 2013-Nov or 2014- Pending
Jan
Approval
PDUFA
Volume 7, Issue 5
Quarter 2, 2013
Prevention of Allergies caused by Grass Pollen Allergen
Dynavax Biologicals New Indication IM 2013-Q2
FDA Filing
Phase III Immunization against Infection Caused by all Known
Subtypes of Hepatitis B Virus in Patients with Chronic Kidney
Disease (CKD)
Ariad Antineoplastics &
Adjunctive Therapies
Novo Nordisk Endocrine & Metabolic
Drugs
New Indication OR 2014-H2
Phase III Treatment of Newly Diagnosed Chronic Myeloid Leukemia
(CML) Patients
FDA Filing
New Combination SC 2013
FDA Filing
Phase III Fixed-Dose Combination Formulation for Type 2 Diabetes
Mellitus (DM)
Alimera; pSivida Ophthalmic Agents New Formulation IO 2013-Oct 1 Pending
Approval
Imprimis Analgesics &
Anesthetics
PDUFA
FDA Filing
Diabetic Macular Edema (DME)
New Formulation EX 2014
Phase III Topical Cream Formulation for Acute Pain
Luitpold Hematological Agents New Formulation IV 2013-Jul 30 Pending
Approval
PDUFA
Iron Deficiency Anemia
RxOutlook® presented by Catamaran Inc. Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative processes.
Data are compiled from both public and private sources. © 2013 Catamaran Inc. All rights reserved. Catamaran is a registered trademark of Catamaran Inc.
17

non-specialty pipeline 2013 to 2016
Product Name
(generic name)
INVEGA SUSTENNA (paliperidone
palmitate)
IONSYS (fentanyl iontophoretic
transdermal system)
ISIS-APOCIIIRx ; ISIS-304801
IXIARO (Japanese encephalitis virus
vaccine, inactivated, adsorbed)
KREMEZIN (carbonaceous oral
adsorbent)
LATUDA (lurasidone HCl)
LATUDA (lurasidone HCl)
LECETTE (desogestrel / ethinyl
estradiol)
Company(ies)
Therapeutic Class Product Type Route
Status Date and
Status Description
FDA Filing
Current
Status
Potential Indication(s)
Alkermes; Janssen CNS Drugs New Formulation IM 2014
Phase III Schizophrenia
Incline Analgesics &
Anesthetics
New Indication EX 2013
Phase III Pain Indications
FDA Filing
Isis Cardiovascular Agents New Molecular Entity SC 2015
FDA Filing
Phase II/III Hypertriglyceridemia
Intercell Biologicals New Indication IM 2013-Early Pending
Approval
PDUFA
FDA Filing
Volume 7, Issue 5
Quarter 2, 2013
Active Immunization for the Prevention of Disease Caused by
Japanese Encephalitis Virus (JEV) in Pediatric Patients
Mitsubishi Tanabe Gastrointestinal Agents New Molecular Entity OR 2013
Phase III Chronic Kidney Disease (CKD)
Sunovion CNS Drugs New Indication OR 2013-Jun 20 Pending
Approval
PDUFA
Sunovion CNS Drugs New Indication OR 2013-Jun 20 Pending
Approval
Teva Endocrine & Metabolic
Drugs
PDUFA
New Formulation OR 2013
Phase III Prevention of Pregnancy
FDA Filing
RxOutlook® presented by Catamaran Inc. Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative processes.
Data are compiled from both public and private sources. © 2013 Catamaran Inc. All rights reserved. Catamaran is a registered trademark of Catamaran Inc.
Monotherapy of Adult Patients with Depressive Episodes
Associated with Bipolar I Disorder
Adjunctive Therapy to Lithium or Valproate for Treatment of
Adult Patients with Depressive Episodes Associated with
Bipolar I Disorder
18

non-specialty pipeline 2013 to 2016
Product Name
(generic name)
LEVADEX (dihydroergotamine)
LIXAR (lixivaptan)
LIXIANA (edoxaban)
LUVENIQ (voclosporin)
LYXUMIA (lixisenatide)
MISOPRESS (misoprostol)
MOXDUO IR (morphine /
oxycodone immediate-release)
MuDelta; JNJ-27018966
Company(ies)
MAP
Pharmaceuticals;
Nektar; Allergan
Therapeutic Class Product Type Route
Analgesics &
Anesthetics
Cornerstone Endocrine & Metabolic
Drugs
Status Date and
Status Description
PDUFA
Current
Status
New Formulation IN 2013-Apr 15 Pending
Approval
New Molecular Entity OR 2013-H1
Complete
Response
Letter
CRL Response
Potential Indication(s)
Acute Treatment of Migraine in Adults
Volume 7, Issue 5
Quarter 2, 2013
Treatment of Symptomatic Hypervolemic and Euvolemic
Hyponatremia Associated with Heart Failure and Syndrome
of Inappropriate Antidiuretic Hormone (SIADH), Respectively
Daiichi Sankyo Hematological Agents New Molecular Entity OR 2013-H2
FDA Filing
Phase III Stroke Prevention in Atrial Fibrillation (AF)
Lux Biosciences Ophthalmic Agents New Molecular Entity OR 2013-Early Complete
Response
Letter
Sanofi Aventis;
Zealand
Endocrine & Metabolic
Drugs
FDA Re-Filing
New Molecular Entity SC 2013-Dec
PDUFA
Pending
Approval
Ferring Genitourinary Products New Formulation VA 2013-Aug 23 Pending
Approval
QRxPharma; Actavis Analgesics &
Anesthetics
PDUFA
New Formulation OR 2013-Aug 26
PDUFA
Pending
Approval
FDA Filing
Uveitis
Type 2 Diabetes Mellitus (DM)
Decreasing Time to Vaginal Delivery in Women with an
Unfavorable Cervix When Used in Sequential Regimen with
Oxytocin Augmentation, if Needed
Moderate to Severe Acute Pain
Furiex Gastrointestinal Agents New Molecular Entity OR 2014-H1
Phase III Diarrhea-Predominant Irritable Bowel Syndrome (IBS-D)
RxOutlook® presented by Catamaran Inc. Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative processes.
Data are compiled from both public and private sources. © 2013 Catamaran Inc. All rights reserved. Catamaran is a registered trademark of Catamaran Inc.
19

non-specialty pipeline 2013 to 2016
Product Name
(generic name)
MYCAMINE (micafungin)
MYCOVA (terbinafine)
NATPARA (recombinant human
parathyroid hormone (PTH) 1-84)
NEXIUM (esomeprazole)
NEXIUM (esomeprazole)
NEXIUM OTC (esomeprazole)
NORTHERA (droxidopa)
NORTHERA (droxidopa)
Company(ies)
Therapeutic Class Product Type Route
Status Date and
Status Description
PDUFA
Current
Status
Astellas Antiinfective Agents New Indication IV 2013-Jul
Pending
Approval
FDA Filing
Potential Indication(s)
ApriCus Antiinfective Agents New Formulation EX 2013-H1
Phase III Onychomycosis
NPS; Takeda Endocrine & Metabolic
Drugs
New Formulation SC 2013-Mid Phase III Hypoparathyroidism
FDA Filing
AstraZeneca Gastrointestinal Agents New Indication OR 2013-Jun Pending
Approval
PDUFA
AstraZeneca Gastrointestinal Agents New Indication IV 2013
PDUFA
Pending
Approval
FDA Filing
Volume 7, Issue 5
Quarter 2, 2013
Expanded Patient Population to Include Pediatric Patients
Aged 4 months to 16 Years Old for Treatment of
Candidemia, Acute Disseminated Candidiasis, Candida
Peritonitis and Abscesses, Esophageal Candidiasis, &
Prophylaxis of Candida Infections in Patients
Reduction in the Risk of Low-Dose Aspirin-Associated Peptic
Ulcers and Peptic Ulcer Bleeding
Peptic Ulcer Bleeding
Pfizer Gastrointestinal Agents Rx to OTC OR 2013-H1
Phase III Heartburn
Chelsea
Therapeutics
Chelsea
Therapeutics
Cardiovascular Agents New Indication OR 2014-H2
Phase III Reducing Falls Associated with Neurogenic Orthostatic
Hypotension (NOH)
FDA Filing
Cardiovascular Agents New Molecular Entity OR 2013-Late Q2 Complete
Response
Letter
FDA Re-Filing
RxOutlook® presented by Catamaran Inc. Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative processes.
Data are compiled from both public and private sources. © 2013 Catamaran Inc. All rights reserved. Catamaran is a registered trademark of Catamaran Inc.
Symptomatic Neurogenic Orthostatic Hypotension (NOH) in
Patients with Primary Autonomic Failure (Parkinson's
Disease, Multiple System Atrophy and Pure Autonomic
Failure), Dopamine Beta Hydroxylase Deficiency and Nondiabetic
Autonomic Neuropathy
20

non-specialty pipeline 2013 to 2016
Product Name
(generic name)
NOXAFIL (posaconazole)
NUVOCID; RAMVOCID (oritavancin)
OCTREOLIN (ocreotide acetate)
ORALAIR (grass pollen allergen
immunotherapy)
OSTARINE (enobosarm)
PA-21
PENNSAID (diclofenac sodium
viscous solution)
POSIDUR (bupivacaine sustained
release)
Company(ies)
Therapeutic Class Product Type Route
Status Date and
Status Description
PDUFA
Current
Status
Merck Antiinfective Agents New Formulation OR 2014-Feb 10 Pending
Approval
Targenta;
Medicines Company
FDA Filing
Potential Indication(s)
Volume 7, Issue 5
Quarter 2, 2013
Prophylaxis of Invasive Aspergillus and Candida Infections in
Patients >/= 13 YO who are at High Risk of Developing these
Infections due to being Severely Immunocompromised
Antiinfective Agents New Molecular Entity IV 2013-Mid Phase III Acute Skin and Skin Structure Infections Caused by Grampositive
Bacteria (ABSSSI)
Chiasma; Roche Endocrine & Metabolic
Drugs
Stallergenes;
Paladin
New Formulation OR 2013-H2
Phase III Acromegaly
FDA Filing
Respiratory Agents New Molecular Entity SL 2013-Nov Pending
Approval
GTx Endocrine & Metabolic
Drugs
Vifor-Fresenius
Medical Care Renal
Pharma
Nuvo Research;
Mallinckrodt
PDUFA
Allergic Rhinitis
New Molecular Entity OR 2013-H2
FDA Filing
Phase III Cachexia/Weight Loss in Patients with Advanced Non-Small
Cell Lung Cancer
Gastrointestinal Agents New Molecular Entity OR 2013-Nov 11 Pending
Approval
Analgesics &
Anesthetics
Durect; Hospira Analgesics &
Anesthetics
PDUFA
New Formulation EX 2013-Q3
FDA Re-Filing
Complete
Response
Letter
FDA Filing
Hyperphosphatemia in Patients with Chronic Kidney Disease
undergoing Hemodialysis
Osteoarthritis of the Knees
New Formulation IM 2013-Early Phase III Postoperative Pain
RxOutlook® presented by Catamaran Inc. Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative processes.
Data are compiled from both public and private sources. © 2013 Catamaran Inc. All rights reserved. Catamaran is a registered trademark of Catamaran Inc.
21

non-specialty pipeline 2013 to 2016
Product Name
(generic name)
PROBUPHINE (buprenorphine HCl
sustained-release)
PROCYSBI (cysteamine bitartrate
DR; mercaptamine bitartrate DR)
QUTENZA (capsaicin)
RANEXA (ranolazine)
RELISTOR (methylnaltrexone
bromide)
RELISTOR (methylnaltrexone
bromide)
REMOXY (oxycodone HCl controlledrelease)
Company(ies)
Titan Misc.
Psychotherapeutic &
Neurological Agents
Therapeutic Class Product Type Route
Status Date and
Status Description
PDUFA
Current
Status
New Formulation SC 2013-Apr 30 Pending
Approval
Raptor Genitourinary Products New Formulation OR 2013-Apr 30 Pending
Approval
NeurogesX Analgesics &
Anesthetics
PDUFA
New Indication TD 2013
CRL Response
Complete
Response
Letter
FDA Filing
Potential Indication(s)
Volume 7, Issue 5
Quarter 2, 2013
Maintenance Treatment of Opioid Dependence in Adults
Nephropathic Cystinosis
Pain Due to HIV-Associated Peripheral Neuropathy (HIV-PN)
Gilead Cardiovascular Agents New Indication OR 2013-Q2
Phase III Coronary Artery Disease in Patients with Type 2 Diabetes
Mellitus (T2DM)
Progenics; Salix Gastrointestinal Agents New Indication SC 2013
CRL Response
Complete
Response
Letter
FDA Filing
Opioid-Induced Constipation (OIC) in Chronic, Non-Cancer
Pain
Salix Gastrointestinal Agents New Formulation OR 2013
Phase III Opioid-Induced Constipation (OIC) in Chronic Pain Patients
Pfizer; Pain
Therapeutics;
Durect
Analgesics &
Anesthetics
New Formulation OR 2013
FDA Re-Filing
Complete
Response
Letter
Moderate to Severe Chronic Pain
RxOutlook® presented by Catamaran Inc. Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative processes.
Data are compiled from both public and private sources. © 2013 Catamaran Inc. All rights reserved. Catamaran is a registered trademark of Catamaran Inc.
22

non-specialty pipeline 2013 to 2016
Product Name
(generic name)
REPLIDEA (calcifediol)
RYTARY (carbidopa / levodopa
extended-release)
RYZODEG (insulin degludec /
insulin aspart)
SATIVEX (nabiximols)
SEEBRI Breezhaler (glycopyrronium
bromide long-acting)
SEFELSA (gabapentin controlledrelease)
STEDESA (eslicarbazepine acetate)
STEDICOR (azimilide)
Company(ies)
Cytochroma Endocrine & Metabolic
Drugs
Therapeutic Class Product Type Route
Status Date and
Status Description
FDA Filing
Current
Status
Potential Indication(s)
Volume 7, Issue 5
Quarter 2, 2013
New Formulation OR 2015-H1
Phase III Secondary Hyperparathyroidism (SHPT) Associated with
Vitamin D Insufficiency in Patients with Chronic Kidney
Disease (CKD)
Impax Neuromuscular Drugs New Formulation OR 2013-Late
CRL Response
Complete
Response
Letter
Novo Nordisk Endocrine & Metabolic
Drugs
GW
Pharmaceuticals;
Otsuka
Analgesics &
Anesthetics
New Combination SC 2016
Complete
Response
Letter
CRL Response
FDA Filing
Parkinson's Disease (PD)
Type 1 and Type 2 Diabetes Mellitus (DM)
New Molecular Entity OR 2013
Phase III Cancer Pain; Spasticity in Multiple Sclerosis (MS)
Vectura; Novartis Respiratory Agents New Formulation IN 2014-Q1
Phase III Chronic Obstructive Pulmonary Disease (COPD)
Depomed; Abbott CNS Drugs New Formulation; New
Indication
FDA Filing
OR 2013-May 31
PDUFA
Pending
Approval
Sunovion Neuromuscular Drugs New Formulation OR 2013-Aug 27 or Pending
Nov 27
Approval
PDUFA
Treatment of Moderate to Severe Vasomotor Symptoms Due
to Menopause
Adjunct Therapy of Partial-Onset Seizures
Forest Cardiovascular Agents New Molecular Entity OR 2015-H1
FDA Filing
Phase III Ventricular Arrhythmia
RxOutlook® presented by Catamaran Inc. Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative processes.
Data are compiled from both public and private sources. © 2013 Catamaran Inc. All rights reserved. Catamaran is a registered trademark of Catamaran Inc.
23

non-specialty pipeline 2013 to 2016
Product Name
(generic name)
STRIVERDI RESPIMAT (olodaterol)
SYNCRIA (albiglutide)
TEKTURNA (aliskiren)
TEKTURNA (aliskiren)
TRESIBA (insulin degludec)
TROKENDI XR (topiramate
extended-release)
UCERIS (budesonide extendedrelease)
VASCEPA (icosapent ethyl)
VIBEX (riboflavin)
Company(ies)
Boehringer
Ingelheim
Therapeutic Class Product Type Route
Status Date and
Status Description
PDUFA
Current
Status
Respiratory Agents New Molecular Entity IN 2013-Apr Pending
Approval
GlaxoSmithKline Endocrine & Metabolic
Drugs
New Molecular Entity SC 2013-Nov 14 or Pending
2014-Jan 14
PDUFA
Approval
FDA Filing
Potential Indication(s)
Volume 7, Issue 5
Quarter 2, 2013
Treatment of Airflow Obstruction in Patients with COPD,
including Chronic Bronchitis and/or Emphysema
Type 2 Diabetes Mellitus (DM)
Novartis Cardiovascular Agents New Indication OR >/= 2015 Phase III Cardiovascular Risk Reduction in the Elderly
Novartis Cardiovascular Agents New Indication OR 2014
Phase III Congestive Heart Failure (CHF)
Novo Nordisk Endocrine & Metabolic
Drugs
FDA Filing
New Formulation SC 2016
Complete
Response
Letter
CRL Response
Supernus Neuromuscular Drugs New Formulation OR 2013-Jun 22
PDUFA
Tentatively
Approved
FDA Filing
Type 1 and Type 2 Diabetes Mellitus (DM)
Treatment of Epilepsy as Monotherapy and Adjunctive
Therapy
Santarus Gastrointestinal Agents Label Expansion OR 2013-Late Phase III Induction of Remission in Patients with Active, Mild to
Moderate Ulcerative Colitis who are Taking Mesalamine
Amarin Cardiovascular Agents New Indication OR 2013-Dec 26 Pending
Approval
PDUFA
Avedro Ophthalmic Agents New Formulation IO 2013-H1
Pending
Approval
RxOutlook® presented by Catamaran Inc. Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative processes.
Data are compiled from both public and private sources. © 2013 Catamaran Inc. All rights reserved. Catamaran is a registered trademark of Catamaran Inc.
PDUFA
Adjunct to Diet in the Treatment of Adult Patients with High
Triglycerides (TG >=200 mg/dL and

non-specialty pipeline 2013 to 2016
Product Name
(generic name)
VIMPAT (lacosamide)
VIVAGELN/A
VYCAVERT (hydrocodone bitartrate
/ acetaminophen)
VYVANSE (lisdexamfetamine
dimesylate)
XARELTO (rivaroxaban)
XIFAXAN (rifaximin)
ZERENEX (ferric citrate)
ZEVEN (dalbavancin)
Company(ies)
Therapeutic Class Product Type Route
Status Date and
Status Description
FDA Filing
Current
Status
Potential Indication(s)
Volume 7, Issue 5
Quarter 2, 2013
UCB Neuromuscular Drugs New Indication OR 2013-H2
Phase III Monotherapy in Adult Patients with Partial Onset Seizures
Starpharma Antiinfective Agents New Molecular Entity 2013-H2
Phase III Symptomatic Relief from and/or Prevention of Recurrence of
Bacterial Vaginosis
Acura Analgesics &
Anesthetics
Shire ADHD / Antinarcotic /
Antiobesity / Anorexic
Agents
FDA Filing
New Formulation OR 2014-H1
Phase III Moderate to Severe Pain
FDA Filing
New Indication OR 2013-Apr 29 Pending
Approval
PDUFA
Janssen; Bayer Hematological Agents New Indication OR 2013-Jul 7 Pending
Approval
PDUFA
Salix Antiinfective Agents New Indication OR 2013-H2
Complete
Response
Letter
CRL Response
Maintenance Treatment in Children and Adolescents Ages 6
to 17 Years with Attention Deficit Hyperactivity Disorder
(ADHD)
In Combination with Standard Antiplatelet Therapy to Reduce
the Risk of Stent Thrombosis in Patients with Acute Coronary
Syndrome (ACS)
Non-Constipation Irritable Bowel Syndrome (IBS) and IBSrelated
Bloating
Keryx; Panacor Gastrointestinal Agents New Formulation OR 2013-H1
FDA Filing
Phase III Hyperphosphatemia in End-Stage Renal Disease (ESRD)
Durata Therapeutics Antiinfective Agents New Molecular Entity IV 2013-Mid Phase III Acute Bacterial Skin and Skin Structure Infections (ABSSSI)
Caused by Susceptible Gram-Positive Bacteria, including
MRSA (methicillin resistant Staphylococcus aureus)
FDA Filing
RxOutlook® presented by Catamaran Inc. Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative processes.
Data are compiled from both public and private sources. © 2013 Catamaran Inc. All rights reserved. Catamaran is a registered trademark of Catamaran Inc.
25

non-specialty pipeline 2013 to 2016
Product Name
(generic name)
ZEVTERA (ceftobiprole medocaril)
ZEVTERA (ceftobiprole medocaril)
ZOELY (nomegesterol acetate / 17
beta-estradiol)
ZOHYDRO ER (hydrocodone
bitartrate extended-release)
ZUBSOLV (buprenorphine /
naloxone)
ZYDENA (udenafil)
Company(ies)
Therapeutic Class Product Type Route
Status Date and
Status Description
FDA Filing
Current
Status
Potential Indication(s)
Basilea Antiinfective Agents New Molecular Entity IV 2013-H1
Phase III Community Acquired Pneumonia (CAP)
FDA Filing
Volume 7, Issue 5
Quarter 2, 2013
Basilea Antiinfective Agents New Molecular Entity IV 2013-H1
Phase III Hospital Acquired (Nosocomial) Pneumonia (HAP)
Merck Endocrine & Metabolic
Drugs
Zogenix; Elan Analgesics &
Anesthetics
Orexo Misc.
Psychotherapeutic &
Neurological Agents
New Formulation OR 2013-H2
Complete
Response
Letter
FDA Re-Filing
New Formulation OR 2013-H1
Pending
Approval
PDUFA
New Formulation SL 2013-Jul 6 Pending
Approval
PDUFA
FDA Filing
Prevention of Pregnancy
Management of Moderate to Severe Chronic Pain in Patients
Requiring Around the Clock Opioid Therapy
Opioid Drug Addiction
Warner Chilcott Cardiovascular Agents New Molecular Entity OR 2013
Phase III Erectile Dysfunction (ED)
RxOutlook® presented by Catamaran Inc. Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative processes.
Data are compiled from both public and private sources. © 2013 Catamaran Inc. All rights reserved. Catamaran is a registered trademark of Catamaran Inc.
26

non-specialty pipeline 2013 to 2016
Product Name
(generic name)
Company(ies)
Therapeutic Class Product Type Route
KEY
Status Date and
Status Description
Current
Status
Potential Indication(s)
Volume 7, Issue 5
Quarter 2, 2013
Product Name – Established or proposed trade name or investigational name
Generic Name – Active ingredient(s) or chemical name
Company(ies) – Company or Companies that are developing the product
Therapeutic Class – Medispan therapeutic class
Product Type – What the product is for investigational products; for products already on the market, what new indications or formulations are in the works (e.g., biologic; device; new molecular entity; new formulation; new combination; new dosing; new
strength; label update, etc.)
Route– What route the product will be administered to a patient (e.g., BU = buccal; CO = combination; DT = dental; EP = epidural; EX = external; IL = implant; IN = inhalation; IJ = Injection; IA = intraarterial; IX = intraarticular; IC = intracavernosal; ID =
intradermal; IG = intragastric; IM = intramuscular; IO = intraocular; IP = intraperitoneal; PL = intrapleural; IT = intrathecal; ITT = intratumoral; IU = intrauterine; IV = intravenous; IS = intravesical; IR = irrigation; MT = mouth/throat; NA = nasal; NS = not
specified; OP = ophthalmic; OR = oral; OT = otic; PF = perfusion; RE = rectal; SC = subcutaneous; SL = sublingual; TD = transdermal; TL = translingual; UR = urethral; VA = vaginal; VI = in vitro)
Status Date – Date by which some action related to the FDA is estimated or scheduled to occur
Status Description – Corresponding action to the status date (e.g., PDUFA, CRL Response; FDA Filing, FDA Re-Filing, or RTF response)
Current Status – What the current status of the drug is (pending approval = under FDA review; Complete Response Letter = FDA requires additional information before the product can be approved; clinical trial phase I, II, or III; FDA Filing = NDA, sNDA,
BLA, sBLA, PMA, etc. expected to be filed with the FDA; PDUFA = date by which FDA is scheduled to make a decision on the product; Pre-Registration = getting ready to file with FDA; Refuse-to-File = FDA did not accept filing)
Indication(s) – what conditions/diseases the product is being investigated for
Prepared by:
Sherry Andes, PharmD, BCPS, BCPP, BCACP, CGP
Drug Intelligence Supervisor
Catamaran
Editor:
Sina Carlson, PharmD
Director, Drug Intelligence
Catamaran
RxOutlook® presented by Catamaran Inc. Drug Intelligence Services. The information contained within this report is subject to change; this information is dependent upon various regulatory and legislative processes.
Data are compiled from both public and private sources. © 2013 Catamaran Inc. All rights reserved. Catamaran is a registered trademark of Catamaran Inc.
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