The Lone Star Pharmacist - September 2018

Volume 4 • September 2018 • Number 1 

The Official Publication of the Texas Society of Health-System Pharmacists – Research & Education Foundation 

Quarterly publication direct mailed to more than 41,000 Pharmacists, Technicians, 

Students and Members of TSHP. 

TSHP President’s Letter 

Texas Report on the 

ASHP 70th House of 

Delegates 

The House of Delegates 

(HOD) is the ultimate 

authority over ASHP 

professional policies, 

which express the Society’s 

stance on important issues 

related to health-system 

pharmacy practice and 

medication use in society. 1 

The sum of the knowledge, 

values, ethics, ideals, and 

aspirations of health-system 

current resident or 

Tammy Cohen, 

PharmD, MS, FACHE, 

FASHP, FTSHP 

pharmacists is reflected in the collective body of ASHP 

professional policies. Members can take pride in this 

core strength of ASHP and should be aware of the 

high expectations that surround their deliberations on 

the latest issues. 2 

ASHP’s democratic policy process allows for 

representation from all 50 states. Texas is allotted 

six seats in the ASHP HOD. The Texas delegates 

are elected by those that are both TSHP and ASHP 

members and for 2018 included Tammy Cohen, 

Shane Greene, Katie Morneau, Sidney Phillips, Ryan 

Roux, and Jeff Wagner. Emily Alexander served as 

the alternate delegate. Joining the Texas delegation 

include ASHP Past Presidents Diane Ginsburg and 

Roger Anderson, and ASHP Section Chair Tricia 

Meyer, who are also from Texas. 

The annual ASHP HOD Delegate cycle starts in 

January when the delegates are seated, followed by 

orientation and the first virtual house meeting held in 

March. The regional delegate conferences are held 

in April and May, were delegates gather to discuss 

the proposed professional policies before the June 

House, potential amendments, and areas of unmet 

policy need. The live HOD meeting is held at the 

Non-Profit Org. 

U.S. Postage Paid 

Princeton, MN 

Permit No. 14 

ASHP Summer Meeting, which was in Denver this 

year. The second virtual HOD meeting is to be held 

in November. 

The annual ASHP HOD Delegate cycle changed 

in 2015 to include virtual meetings. The virtual 

meetings are held in the spring and fall, to provide 

an opportunity for delegates to debate and vote on 

policy recommendations in a timelier fashion, making 

the ASHP policy process more responsive. 1 

The 1st Virtual HOD meeting was held March 

16-23, 2018. The delegates voted on voted on 

ten policy recommendations. Delegates approved 

nine recommendations by more than 85 percent, 

the threshold set by the Board Task Force on 

Organizational Structure for final approval and 

declined one recommendation. The approved policies 

are as follows: Unit Dose Packaging Availability; 

Gene Therapy; Medications Derived from Biologic 

Sources; Role of Pharmacists and Business Leaders 

in Health Care Services and Policies; Confidence 

in the U.S. Drug Approval and Regulatory Process; 

Size, Color, and Shape of Drug Products; Drug 

Dosing in Conditions that Modify Pharmacokinetics 

or Pharmacodynamics; Appropriate Dosing of 

Medications in Patient Populations with Unique Needs; 

and DEA Scheduling of Hydrocodone Combination 

Products. The policy recommendation that did not 

achieve the 85 percent threshold for approval was 

Pharmacy Practice Training Models, which was later 

reviewed and edited at the June meeting. 

Details can be found at http://bit.ly/2JbYFkq. 

The 70th HOD meeting was held at the ASHP 

Summer Meeting June 2-6, 2018 in Denver, CO. 

The Delegates attended the open forum, multiple 

caucuses, and delegate meetings. The delegates 

reviewed and commented on 31 policies and 

resolutions and several were amended through the 

process. On Day Two of the HOD, Texas delegates 

submitted two recommendations. Texas Delegate 

Inside... 

Foundation Welcomes Next President.............. 2 

TSHP 2018 Annual Seminar..................... 3 

The Community is Advancing. Grow with Us ......... 3 

TSHP Career Center........................... 4 

Pharmacy Management Corner .................. 4 

TSHP R & E Foundation Contribution Form .......... 4 

Katie Morneau entered a recommendation regarding 

active involvement in organizations and Texas 

Delegate Tammy Cohen entered a recommendation 

on Pharmacist involvement in the post-acute setting. 

Both recommendations will be taken back to ASHP 

for review, processing and potential assignment to a 

council. In addition to policy work, the HOD held the 

election for the 2018-2021 chair of the HOD. Casey 

White from Tennessee was elected and installed 

at the conclusion of the meeting and will serve as 

the chair for the upcoming three years. Casey has 

been a delegate for Tennessee for the last ten years 

and worked with Texas delegates over the years on 

various policy recommendations. 

Details can be found at www.ashp.org/House-of- 

Delegates. 

“ASHP House of Delegates”. American Society of 

Health System Pharmacists. Web Wed 05 July 

2017. 

Why Professional Policies Matter. Am J Health-Syst 

Pharm—Vol 66. Jun 1, 2009. 

Alcalde Save the Date ......................... 4 

TSHP Calendar of Events ....................... 5 

TSHP Announces Officer Election Results. ........... 5 

Happy Pharmacy Month. . . . . . . . . . . . . . . . . . . . . . . . 5 

New Practitioner Corner. ....................... 6 

FDA New Drugs May ‘18 -July‘18. ................ 7

Page 2 September 2018 The Lone Star Pharmacist 

Foundation Welcomes 

Next President 

In April, the TSHP 

Research & Education 

Foundation installed their 

next President, Rebecca 

B. Sleeper-Irons, PharmD, 

FCCP, FASCP, BCPS. 

Rebecca’s is currently the 

Professor and Associate 

Dean of Curriculum at Texas 

Tech University Health 

Science Center School of 

Pharmacy in Lubbock, TX. 

As she begins her term, 

and on behalf of the TSHP 

R&E Foundation Board of 

Rebecca B. Sleeper- 

Irons, PharmD, FCCP, 

FASCP, BCPS 

Directors, she would like to extend a sincere thank 

you for your continued support of the Foundation and 

for your belief in the future of pharmacy in Texas. 

TSHP Research & Education 

Foundation Board of Directors 

Officers 

President 

Rebecca B. Sleeper-Irons, PharmD, 

FCCP, FASCP, BCPS 

Professor and Associate Dean of Curriculum, 

Texas Tech University School of Pharmacy 

Treasurer 

Bradi L. Frei, PharmD, MSc, BCOP, BCPS 

Associate Professor, University of the Incarnate 

Word, Feik School of Pharmacy 

Oncology Clinical Specialist, University of 

Texas Health Science Center at San Antonio 

Secretary 

Kimberly Putney, PharmD, MPH 

Manager, Clinical Pharmacy, Baylor 

St. Luke’s Medical Center 

Director (Non-Pharmacist) 

Beth Walgren, MBA 

Ipsen, Oncology Regional Sales Director 

Directors 

Lourdes Cuellar, MS, RPh 

Bonnie Dugie, PharmD, MBA, MTM 

Larry Egle, PharmD, MS, MBA 

Diane Kretschmer, RPh, PharmD 

Stewart Wirebaugh, PharmD 

Butch Habeger, RPh, MBA, FASHP, FTSHP 

Fred Mullin, MBA, RPh 

Alcalde, Executive Director 

Linda S. Albrecht, MBA, RPh, FASHP, FTSHP 

TSHP Executive Committee Liaison 

Steven Knight, PharmD, BCPS, RPh, CMTM 

Contact the TSHP Office for information 

about upcoming issues or to suggest 

content ideas. Contact TSHP at 

512-906-0546 or at 

Jenni.Peters@tshp.org. 

For advertising rates and information, please 

contact Arthur L. Davis Publishing Agency, Inc., 

517 Washington Street, PO Box 216, Cedar Falls, 

Iowa 50613, (800) 626-4081, sales@aldpub.com. 

TSHP – R&E Foundation and the Arthur L. Davis 

Publishing Agency, Inc. reserve the right to reject any 

advertisement. Responsibility for errors in advertising is 

limited to corrections in the next issue or refund of price 

of advertisement. 

Acceptance of advertising does not imply 

endorsement or approval by the Texas Society of 

Health-System Pharmacists – Research & Education 

Foundation of products advertised, the advertisers, 

or the claims made. Rejection of an advertisement 

does not imply a product offered for advertising is 

without merit, or that the manufacturer lacks integrity, 

or that this association disapproves of the product 

or its use. TSHP – R&E Foundation and the Arthur L. 

Davis Publishing Agency, Inc. shall not be held liable 

for any consequences resulting from purchase or use 

of an advertiser’s product. Articles appearing in this 

publication express the opinions of the authors; they 

do not necessarily reflect views of the staff, board, or 

membership of TSHP – R&E Foundation or those of 

the national or local associations. 

The Official Publication of the Texas Society of Health-System Pharmacists – R&E Foundation

The Lone Star Pharmacist September 2018 Page 3 

The Community is Advancing. Grow with Us. 

A message from the Chair of TSHP’s Membership Development Council 

It’s hard to believe 

Summer has come and 

gone. It seems like the 

TSHP Annual Seminar 

in The Woodlands was 

only yesterday! Hopefully 

everyone had a great 

summer. During this time, 

TSHP has been working 

hard post-seminar, gearing 

up for 2018-19 with new 

initiatives and begun Jesse Chaffino 

preparation for next year’s 

event in Frisco, TX. As successful as this past April 

was, no doubt next year will be bigger and better! 

With Fall upon us, do not forget “Pharmacy Month” 

is around the corner. Each year, October celebrates 

Pharmacy Week (Oct 14-20), as well as National 

Pharmacy Technicians Day (Oct 16). TSHP celebrates 

by acknowledging and recognizing the hard work of 

our members and pharmacy professionals across the 

state. Be sure to follow us on Facebook (@TexasSHP), 

Twitter (@TSHP_org), and LinkedIn to see what your 

colleagues around the state are up to. It’s all about 

being #PharmacyStrong! 

“Pharmacy Month” is also a time where we tie 

in one of our largest membership drives of the year. 

With the TSHP Local Chapter Challenge competition 

in full swing, this is an excellent opportunity to support 

your local chapter by becoming a member and help 

your Chapter gain bragging rights! Who will unseat 

the reigning champs, El Paso Area SHP? Or will they 

repeat as “Best of TSHP” for Membership Growth? 

If you are already a member of TSHP, the best thing 

you can do is refer a friend! Refer 5 new members 

and receive $25 off you next membership renewal 

through the Refer-A-Friend Program. Visit www.tshp. 

org/referral for details. 

Community members already know the benefits 

of staying involved with TSHP — networking 

opportunities, legislative support, local chapter 

activities, scholarships (students, technicians, & 

residents), research grants, mentoring, and many other 

member-only benefits. There’s something for everyone! 

Plus, members receive up to $100 off Annual Seminar 

registration. Visit www.TSHP.org to learn about all 

Support the 

future of 

Pharmacy 

DONATE 

TODAY 

the benefits, resources, and most importantly, how to 

JOIN!! Grow with us as we launch new benefits and 

services this year and in the coming years! 

As Membership Council Chair and on behalf of 

your TSHP leadership team, I would like to thank our 

members for being a part of our growing Society! 

More than ever, TSHP is working hard to give back 

to members and we are constantly striving to enhance 

member benefits. It is also about recognizing everyone 

in the pharmacy profession, and this October, we 

celebrate your hard work and contributions to patient 

care. Thank you for all you do! 

Until next time, enjoy football season! Go 

Cowboys*! We look forward to seeing many of you 

in December at ASHP Midyear in California for the 

Texas Reception! And don’t forget, with your help 

through the TSHP community, we truly are Pharmacy 

Leaders. Transforming Patient Care. 

*TSHP is not affiliated with any one professional sports team. 

Fandom expressed in this article is the opinion of the current 

Membership Chair and author of this article, Jesse Chaffino. 

TSHP TSHP R&E R&E Foundation 

Foundation 

Supporting 

Supporting 

Texas 

Texas 

pharmacy 

pharmacy 

students 

students 

through 

through 

scholarships 

scholarships since 

since 

1977 

1977 



Pharmacy Management Corner 

“ 

The Pharmacy Degree 

affords one the 

opportunity to pursue 

whatever one dreams. 

” 

I have shared this with 

future, current, and graduate 

pharmacy students over 

decades of mentorship. I 

share it with our pharmacy 

community in this, my first 

article highlighting the TSHP 

Pharmacy Management 

Section initiatives for 2018 

and 2019. It speaks to the 

Tony Palmer, RPh, 

DBA 

TSHP 2018- 

2019 Pharmacy 

Management Section 

Chair 

Section’s passion to serve our membership and our 

profession. 

The TSHP Pharmacy Management Section 

Executive Committee engaged in a robust first 

planning meeting mid-June. The Section’s initiative for 

the design, in collaboration with the TSHP Education 

Council, of the management CE tracks for the 2019 

Annual Meeting is developing. The CE track will 

focus on enhancing the value of institutional clinical 

management practice covering a variety of topics. I 

invite you to check back as more to come on this in 

future issues. 

Working with the TSHP Membership Council, 

our Section, supports as an initiative, the TSHP 

goal to suggest new member benefits to elevate 

the value membership to our community. Employee 

engagement, clinical benchmarking best practices, 

measurement of clinical impact, and repositioning 

the pharmacist role were discussed by the Section 

Executive Committee during our first meeting. I ask 

the Section membership to email me tony.palmer@ 

unthsc.edu or Kathryn Merkel our Section’s Chair- 

Elect at KGMerkel@ascension.org with suggested 

TSHP membership benefits that would assist you in 

your daily challenges. 

If you are interested or have questions/suggestions 

regarding our TSHP Pharmacy Management Section, 

please contact me or Kathryn. We look forward 

to working with our fellow Pharmacy Management 

professionals and the TSHP community. 

SAVE THE DATE 

April 10-11, 2019 | Frisco, TX 

www.tshp.org/alcalde 

TSHP 

TSHP 

Career Career Center Center 

Connecting Talent 

Connecting Talent 

with Opportunity 

with Opportunity 

www.tshp.org/cc 

www.tshp.org/cc 

Your support has impacted so many. 

Your continuted contribution 

will help many more. 

Since 1977, the TSHP R&E Foundation has been 

helping the future of pharmacy in Texas – students, 

practitioners, technicians, and leaders. With each 

passing year, the need increases. 

A student at a typical state-supported college of 

pharmacy pays: 

• $10,000 per semester for tuition and fees 

• An average of $250 per book 

• Approximately $1,200 per 

month for a dorm room 

• Not to mention transportation 

& living expenses 

Contribution to our scholarships make all the 

difference in a student’s life. 

The R&E Foundation asks for your support. Help 

someone in honor of those who helped you. We 

are all part of a profession that recognizes the 

need to nurture a strong pharmacy foundation for 

each other, our patients, and for the future of our 

profession. 

The Foundation supports more than scholarships. 

Through contributions to the R&E Administrative 

Fund, we fund research grants, the annual R&E 

Poster Competition and Clinical Skills & Disease 

State Management Competitions, as well as 

provide support for residency programs and the 

annual Alcalde Southwest Leadership Conference. 

We are proud to be able to gift thousands of 

dollars in scholarships and awards every year, 

thanks to you. Our strong future is supported 

entirely by pharmacists, technicians, and friends of 

pharmacy, like you, who honor the legacy of the 

pharmacy profession and its leaders. 

TSHP RESEARCH & EDUCATION 

FOUNDATION CONTRIBUTION FORM 

CONTRIBUTOR INFORMATION 

Name:_______________________________________ 

Email:________________________________________ 

Address:_____________________________________ 

City/State/Zip:________________________________ 

Phone:_______________________________________ 

PLEDGE CONTRIBUTION 

I pledge $______________ per year, for______years. 

ONE-TIME CONTRIBUTION 

$1,000 $500 $250 $100 

$50 $25 $_______________ 

MY CONTRIBUTION SHOULD SUPPORT: 

Paul & Beth Davis Administrative Fund 

(internship program, poster competition, 

& general operations) 

Other____________________________________ 

PAYMENT INFORMATION: 

Enclosed 

Bill Me 

Makes checks payable to TSHP R&E Foundation 

Card #:______________________________________ 

Exp:_________________________________________ 

CVV: ________________________________________ 

Billing Address:________________________________ 

City/State/Zip:________________________________ 

Name on Card________________________________ 

Signature: ____________________________________ 

or contribute online at 

www.tshp.org/donate 



TSHP Calendar 

of Events 

September 2018 

All month Call for Presentations for Annual Seminar 2019 

All month 

September 15 

September 17 

October 2018 

All month 

October 20 

October 31 

November 2018 

All month 

November 2 

November 6 

November 18 

December 2018 

December 2 

December 2-6 

TSHP Journal article submissions accepted 

Central Texas Society of Health-System 

Pharmacists (CTSHP) Seminar 

ASHP Texas Delegate Call for 

Nominations opens 


Austin Area Society of Health-System 

Pharmacists (AASHP) Seminar 

CAB Bond Memorial Research 

Grant application closes 


UHCOP Residency Showcase 

TSBP Board Business Meeting – Austin, TX 

ASHP Texas Delegate Call for 

Nominations closes 

Texas Reception at ASHP Midyear 

ASHP Midyear – Anaheim, CA 

TSHP Announces Officer 

Election Results 

Sarah Lake-Wallace, MS, PharmD, FTSHP, has been 

elected the 2018-19 TSHP President-Elect Designee. For 

the past three years, Sarah has been the pharmacy 

manager for TIRR Memorial Hermann in Houston. Sarah 

has served in many capacities for TSHP, including service 

as a council chair for multiple councils and as a clinical 

skills coordinator. Sarah also served on the R&E Foundation 

Board of Directors for nine years, serving as their president 

for her last two years on the board. 

Randy Martin, PharmD, BCCP has been elected as the 

2018-19 TSHP Treasurer-Elect. Randy is currently Associate 

Dean for Clinical Affairs at University of North Texas System 

College of Pharmacy, a Fellow for the Institute of Patient 

Safety, and an Associate Professor of Pharmacotherapy. 

Randy has been an active and involved member of TSHP 

since 2004, serving in three elected officer positions. 

Please join us in congratulating Sarah & Randy! 

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New Practitioner Corner 

Now’s the time to join the TSHP New Practitioner Section 

Hongmei Wang 

Justin Shanks 

Hongmei Wang, PharmD, PhD, BCPS 

and Justin Shanks, PharmD 

Are you a recent graduate in your first 

five years of practicing pharmacy? 

Are you looking for ways to advance your career? 

If so, we can help. As a member of the TSHP New 

Practitioner (NP) Section you have the opportunity 

to explore mentorship, learn skills & knowledge to 

tackle workplace challenges, expand your clinical 

competence, and develop leadership skills. 

New practitioners have unique needs, interests, and 

concerns that are often different from more experienced 

members of the profession. The objective of TSHP’s NP 

Section is to provide an avenue of support to assist 

with the many challenges that come with transitioning 

from a student to a practicing health-system or hospital 

pharmacist. The volunteer leadership of the TSHP 

New Practitioner Section Committee (NPSC) strives 

to serve TSHP and the members of the NP Section 

through several ongoing initiatives intended to enrich 

member experiences, benefits, continuing education, 

and volunteer opportunities. We are excited about the 

new initiatives launching this year and look forward 

to you taking advantage of them, as we strive to 

better serve you and the members of the TSHP New 

Practitioner Section! 

Do you feel like you are in over your 

head trying to advance your career? 

Learn how to potentially navigate some of these 

challenges through the TSHP Mentorship Program! 

Participation in the TSHP Mentorship Program is 

open to pharmacy students, new practitioner and 

pharmacist members. It is often considered one of 

the most valuable initiatives, as it benefits not only 

new practitioners but students and more experienced 

members alike. Volunteers from the NPSC match 

interested mentors with mentees based on practice 

area interest and location to facilitate a relationship 

that will hopefully continue to grow through the years. 

Mentees will learn from the wealth of experience of 

their mentor and the mentor will benefit from further 

developing their precepting and coaching skills with 

matched mentees of similar interests. Additionally, 

mentees will have direct access to their mentor’s tips, 

tricks, and best practices that they used to make their 

career both successful and rewarding. Helping shape 

the future of pharmacy in Texas! 

offering content that enriches new practitioner skills, 

as well as addressing other pertinent issues specific to 

our career stage. The NPSC actively seeks presenters 

for CE topics from both 

inside and outside of the 

TSHP membership and the 

new practitioner section. 

If you are interested 

in speaking at Annual 

Seminar or presenting/ 

proposing a CE topic, 

please contacting us! We 

would like input from new 

practitioners on what CE 

topics are most pertinent 

to you, that you believe 

would benefit other new 

practitioners. Additionally, 

the NP section is in the development and planning 

process of potentially offering more online CE. We 

know practice can be overwhelming but learning 

through online CE exercises is one way to brush up 

on therapeutic topics and expand your knowledge 

base, another great opportunity for professional topic 

presentation and collaboration. 

Are you having trouble meeting colleagues that 

can help get you where you want to go? 

Our members have access to many networking 

opportunities to meet fellow new practitioners and 

practitioners, as well as TSHP members in leadership/ 

management positions across the great state of Texas. 

The TSHP Annul Seminar is the largest gathering of 

health-system and hospital pharmacy professionals in 

Texas. The networking and social opportunities at the 

Annual Seminar may just be the single best resource 

for you to learn about opportunities you need to 

navigate up the career ladder. 

Looking for ways to supplement your CV or 

improve your teamwork and leadership skills? 

The New Practitioner Section offers many 

leadership opportunities to set yourself apart. All NP 

members are eligible to apply for an opportunity to 

serve on the New Practitioner Section Committee. 

This Committee consist of NPs from across Texas who 

meet and collaborate with local, state, and national 

leaders on our various initiatives designed to serve 

not only NPs, but all TSHP. One such initiative is our 

college outreach initiative where Committee members 

reach out to schools of pharmacy across the state 

to speak about opportunities within health-system and 

hospital pharmacy and current pharmacy issues. The 

Why should I join TSHP New 

Practitioner Section? 

• Reduced membership dues the first 

five years following graduation 

• Discounted Annual Seminar registration 

• Leadership and career development 

• Networking/Mentorship/Menteeship 

• Publications/Speaker Opportunities 

presentations include information about the TSHP 

Annual Seminar, residencies, Mentorship Program, 

opportunities to serve within TSHP, and more! The NPSC 

encourages all interested 

new practitioners to get 

involved and consider 

applying for a position 

during the next Call for 

Volunteers in the spring. 

Additionally, we would 

encourage all practitioners 

to get involved with one of 

the many local chapters 

throughout Texas. 

This year, the NP Section 

has begun distributing 

a section newsletter 

and monthly brief. This 

newsletter includes clinical pearls, information about 

state and local events, accomplishments, membership 

testimonials, and much more! Members can look 

forward to continued editions of this communication 

to stay informed and involved. If you wish to receive 

this communication and are not a member, please visit 

www.tshp.org/join or contact one of the NP Section 

Chairs listed below. 

We are always looking for new ways to help our 

fellow new practitioners. The possibilities are endless 

and the level of commitment is totally up to you. The 

important thing is to get involved. Help ensure your 

success and a rewarding career; join the TSHP New 

Practitioner Section TODAY! 

If you would like additional information, please feel 

free to contact us! 

Chair – Hongmei Wang (hongmei.wang@tsu.edu) 

Chair-Elect – Justin Shanks (jds117bus@gmail.com) 

Have you had difficulty continuing to strengthen 

your clinical practice or teaching skills since 

finishing pharmacy school or residency? 

The TSHP NPSC develops educational 

programming for the TSHP Annual Seminar, specifically 

aimed at polishing the skills of new practitioners. 

Annual Seminar CE is planned with the intent of 



FDA New Drugs • May ‘18 - July ‘18 

Approval Date Drug Name Active Ingredients Submission Classification Review Priority ** Company 

5/4/2018 PLENVUNDA #209381 ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; Type 2 - New Active Ingredient Standard SALIX PHARMS INC 

POTASSIUM CHLORIDE; SODIUM ASCORBATE; 

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5/15/2018 LAMIVUDINE AND TENOFOVIR DISOPROXIL LAMIVUDINE; TENOFOVIR 

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FUMARATENDA #022344 

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5/17/2018 AIMOVIGBLA #761077 ERENUMAB-AOOE AMGEN INC 

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5/24/2018 HALOBETASOL PROPIONATENDA #210566 HALOBETASOL PROPIONATE Type 3 - New Dosage Form and Type 4 - New Combination Standard THERAPS INC 

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6/29/2018 ARISTADA INITIO KITNDA #209830 ARIPIPRAZOLE LAUROXIL Type 5 - New Formulation or New Manufacturer Standard ALKERMES INC 

6/29/2018 FULVESTRANTNDA #210326 FULVESTRANT Type 5 - New Formulation or New Manufacturer Standard FRESENIUS KABI USA 

7/9/2018 Atropine Injection, 2 mg/0.7 mL, ATROPINE Priority RAFA LABLTD 

Single-Dose AutoinjectorNDA #212319 

7/10/2018 VANCOMYCIN HYDROCHLORIDENDA VANCOMYCIN HYDROCHLORIDE Type 5 - New Formulation or New Manufacturer Standard MYLAN LABS LTD 

#209481 

7/11/2018 GLYRX-PFNDA #210997 GLYCOPYRROLATE Type 5 - New Formulation or New Manufacturer Standard EXELA PHARMA SCS LLC 

7/12/2018 BORTEZOMIBNDA #209191 BORTEZOMIB Type 5 - New Formulation or New Manufacturer Standard HOSPIRA INC 

7/13/2018 TPOXXNDA #208627 TECOVIRIMAT Type 1 - New Molecular Entity Priority SIGA TECHNOLOGIES INC 

7/16/2018 INFUGEMNDA #208313 GEMCITABINE 0.9%;SODIUM CHLORIDE Type 3 - New Dosage Form Standard SUN PHARM INDS INC 

7/17/2018 SYMTUZANDA #210455 DARUNAVIR;COBICISTAT;EMTRICITAB Type 4 - New Combination Standard JANSSEN PRODS 

INE;TENOFOVIR ALAFENAMIDE 

7/20/2018 KRINTAFELNDA #210795 TAFENOQUINE Type 1 - New Molecular Entity Priority GLAXOSMITHKLINE 

7/20/2018 TIBSOVONDA #211192 IVOSIDENIB Type 1 - New Molecular Entity Priority AGIOS PHARMACEUTICALS INC 

7/23/2018 ORILISSANDA #210450 ELAGOLIX SODIUM Type 1 - New Molecular Entity Priority ABBVIE INC 

7/24/2018 DOXERCALCIFEROLNDA #208614 DOXERCALCIFEROL Type 5 - New Formulation or New Manufacturer Standard HOSPIRA INC 

7/27/2018 OMEGAVENNDA #210589 FISH OIL TRIGLYCERIDES Type 1 - New Molecular Entity Priority FRESENIUS KABI USA 

7/30/2018 REMODULINNDA #208276 TREPROSTINIL Type 3 - New Dosage Form Standard UNITED THERAP 

7/30/2018 AZEDRANDA #209607 IOBENGUANE I 131 Type 5 - New Formulation or New Manufacturer Priority PROGENICS PHARMA INC 

7/31/2018 MULPLETANDA #210923 LUSUTROMBOPAG Type 1 - New Molecular Entity Priority SHIONOGI INC 

* NDA Submission Classifications 

For details, see FDA/CDER MAPP 5018.2 

Type 1 New molecular entity 

Type 2 New active ingredient 

Type 3 New dosage form 

Type 4 New combination 

Type 5 New formulation or other differences 

Type 6 New indication or claim, same applicant [no longer used] 

Type 7 Previously marketed but without an approved NDA 

Type 8 Rx to OTC 

Type 9 New indication or claim, drug not to be marketed under type 9 NDA after approval 

Type 10 New indication or claim, drug to be marketed under type 10 NDA after approval 

Type 1/4 Type 1, New molecular entity, and Type 4, New combination 

Type 2/3 Type 2, New active ingredient, and Type 3, New dosage form 

Type 2/4 Type 2, New active ingredient and Type 4, New combination 

Type 3/4 Type 3, New Dosage Form, and Type 4, New combination 

** Review Priority 

Priority: 

Review designation assigned to applications for drugs that treat serious conditions and provide significant improvements in 

the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions compared to available therapies 

Standard: 

Review designation assigned to applications for drugs that do not meet the priority review designation criteria

The Lone Star Pharmacist - September 2018

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