The Lone Star Pharmacist - December 2018

Volume 4 • December 2018 • Number 2
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
How The Texas
Society of Health
System Pharmacists are
leading the way
It has been a very
busy year for TSHP. This
article is being dedicated
to providing a summary
of some of the exciting
activities underway, call
for nominations and
invitations.
Updates on Member
Activities:
One focus of this year
Tammy Cohen,
BS, MS, PharmD,
FTSHP, FASHP,
FACHE
has been on providing educational opportunities
at times and in ways that best meet our member
needs. TSHP has already hosted two online CE
program for pharmacist and technician members.
The October program called “USP Chapter
Compliance: An Update” was well
attended and now available for online homestudy
CPE completion. Thank you, Katrina Harper,
PharmD for providing the update. In November,
a course geared toward the New Practitioners,
“The Path to Preceptor Status” presented by Vicki
Howe, PharmD received great reviews and will
be available soon as an online CPE course. Both
courses are presented free to TSHP members.
The TSHP Editorial Advisory Board and
Executive Leadership is pleased to announce
the relaunch of TSHP’s official publication, TSHP
Journal. TSHP Journal is an exciting online journal
covering pertinent research to the practice of
pharmacy in hospitals and health-systems. The
journal relaunch represents a positive step toward
advancing pharmacy practice and education in
Texas. Read the relaunch issue – “Different Sides
of the Opioid Epidemic” – now at www.tshp.org/
journal.
TSHP is a member of the Texas Pharmacy
Summit which meets regularly to discuss pharmacy
legislative topics to align the various pharmacy
organizations and their respective legislative
goals. The Summit is in full swing in preparation
for the 2019 Texas legislative session. TSHP will
be bringing forward the TSBP cleanup bill in
the upcoming session. Stay tuned for pharmacy
updates on the 86th legislative session as it gets
underway.
TSHP is also a member of the Texas Pharmacy
Congress. The members discussed and worked on
the vision for the future of pharmacy
at the August 2018 meeting, in
which the Congress celebrated its
30th anniversary.
Call for Nominations:
This is a special time of year in
which many calls for volunteers go
out. The call for TSHP officers and
annual awards nominations are
underway. Please take a few minutes
to nominate great pharmacists and
technicians to one or more of these
great opportunities. Visit www.tshp.
org for details.
Invitations:
I’d like to personally invite you to Frisco, TX for
the largest educational and networking meeting
of pharmacists, students, technicians and industry
professionals in the state of Texas. The TSHP
Annual Seminar will be held April 12-14th at the
Embassy Suites Dallas-Frisco Hotel, Convention
Center, and Spa. The event will have over 40
hours of continuing education programming
including a Texas pharmacy law update and
preceptor education. The installation and awards
program will be Saturday and the Residency and
Career Showcase will be Friday from 1:00 –
3:00 PM. Additionally, several competitions will
be held including the posters, clinical skills, and
management case studies. The meeting is sure
to have something for everyone. See the TSHP
website for details: www.tshp.org/seminar. I look
forward to seeing you there!
REGISTER NOW
April 10-11, 2019 | Frisco, TX
www.tshp.org/alcalde
current resident or
Non-Profit Org.
U.S. Postage Paid
Princeton, MN
Permit No. 14
Inside...
TSHP Research & Education Foundation ............ 2
2018 Scholarship Recipients..................... 2
Pharmacy Management Corner .................. 3
New Practitioner Corner........................ 3
Technician Corner............................. 4
Student Corner .............................. 4
Make it your New Year’s Resolution!. .............. 5
New Practitioner Testimonial .................... 5
TSHP Calendar of Events ....................... 6
FDA New Drugs August ‘18-October ‘18 ............ 7

Page 2 December 2018 The Lone Star Pharmacist
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 December 2018 Page 3
Pharmacy Management Corner
“How does one design a sustainable
professional leadership career?”
I discuss this question
often with my IPPE and
APPE students. And now, I
share this with our pharmacy
community in this, the
December issue of Lone Star
Pharmacist. I am inspired by
the Management Section’s
Executive Committee’s
(MSEC) passion to lead our
professional endeavors.
The MSEC recently
submitted its proposed
Management CE Track topics
for the 2019 TSHP Annual
Tony Palmer, RPh,
DBA
TSHP 2018-
2019 Pharmacy
Management Section
Seminar. The
central theme
for the CE Track in
2019 is Sustainable
Career and Leadership
Planning with a focus
on enhancing the
value of institutional
Please contact me at
tony.palmer@unthsc.edu,
if there is
anything
we can
do for you.
clinical management practice. This CE Track
speaks to the Section’s passion to serve our
membership, our profession, and the development
of pharmacy health system leaders.
The second annual TSHP Leadership Challenge
Chair Pharmacy Management Corner Continued on pg. 6
New
Practitioner
Corner
Food, Fun,
Friendship, and CEs
Are you a new
pharmacist looking for
resources to help you grow
your career? Attending the
Annual Seminar on April
12-14, 2019, in Frisco, TX
is a great way to jumpstart
your goals. Every year,
the New Practitioner
Section leadership designs
CEs targeted for the
unique challenges new
practitioners face and
current hot topics we want
to learn more about. All
work and no play make
Jack a dull pharmacist,
so we will also have
opportunities to relax and have fun.
Jenny Benjamin,
PharmD
New Practitioner
Section Committee
Annual Seminar
Education Track Team
Lead
The New Practitioner Town Hall Meeting is
where we can share ideas for improvements to the
organization. All new practitioners are encouraged
to attend – members and non-members alike, and it
is important that we hear your voice! This is a prime
opportunity for new practitioners across the state to
gather and share our opinions. This year, we would
like to socialize and network after the President’s
Reception to keep the party going.
Keep an eye on your email and www.tshp.
org/seminar for more details on times, places, and
events. As the section chairs for Annual Seminar, we
are excited to meet all of you! If you want to be
more involved and learn more about opportunities
for leadership, presentations, and service, make
plans now to attend the 2019 Annual Seminar to
experience a few of the things TSHP has to offer you,
a member of our pharmacy community.
The Official Publication of the Texas Society of Health-System Pharmacists – R&E Foundation
is

Page 4 December 2018 The Lone Star Pharmacist
Technician Corner
The Benefits of Membership
Several years ago, a credit card company used
the slogan “membership has its privileges” and during
that campaign, their advertisements concentrated on
showing all the benefits of being a card member. When
asked why join TSHP, I think of that slogan and I say
“membership has its benefits.”
The benefit that comes to mind first is discounted
registration for TSHP Annual Seminar. Yes, that is
an excellent financial benefit because your annual
membership and your Annual Seminar registration
together cost only a $1 more than a non-member
registration fee. But there are many more benefits of
being a member of the TSHP community that even more
valuable than the Seminar discount.
TSHP benefits extend throughout the year by
Leon Jacobs, CPhT,
PhTR
TSHP Technician
Section Chair
expanding our minds, keeping us connected, and being a voice for our profession.
Forum discussions, articles in the bi-weekly email newsletter, TSHP Bulletin and the
recently relaunched electronic publication, TSHP Journal, and the quarterly print
publication, The Lone Star Pharmacist are just some benefits that are available
for professional growth. Members are connected to colleagues across the
state of Texas with access to the member directory, to job opportunities through
the TSHP Career Center, and to Texas State Board of Pharmacy activities from
board reports. As a member, you have the benefit of having a voice within an
organization that is championing for our profession and supporting our profession
through advocacy.
Besides the benefits mentioned above, continuing education hours are a definite
benefit. The Technician Section Executive Committee members are in the process
of finalizing 10+ CE hours of topics for the TSHP 2019 Annual Seminar in Frisco,
TX. Topics will be relevant and current to health-system pharmacy technicians.
Remember, membership has its benefits. Want to learn more? Visit www.
tshp.org/join, call Jenni at (512) 906-0546, or email her at membership@tshp.org.
Student Corner
Student Health is Our Health
The pharmacist’s role has grown beyond
the stereotypical dispensing and distribution of
medications. Today, pharmacists are a valued part of
the healthcare team, providing a vast knowledge of
medication therapy and offering guidance on patient
outcomes. Pharmacists offer an accessibility that is rare
among healthcare professionals. Located close to the
communities they serve, pharmacists provide numerous
public health services, in some cases 24-hours per day.
Even at a point where there are so many pharmacy
schools in Texas with more being planned, there are
still rural and underserved areas without adequate
access to healthcare professionals. Now more than
ever, pharmacists are filling the void in access to care
and prevention.
Bringing awareness to just how integral pharmacists
are in improving public health through education, prevention, and influencing
healthy outcomes is especially important during our formative pharmacy education.
Students coming into the profession now do not realize just how far the profession
has evolved. It is the responsibility of all pharmacy practitioners, from tech to intern
to pharmacist, to advocate for our role in public health.
Participating in health-related service projects like opioid awareness programs,
disaster preparedness simulations, disease
“It is the responsibility
of all pharmacy
practitioners, from
tech to intern to
pharmacist, to
advocate for our role
in public health.”
Andrew Ramirez,
Student Pharmacist,
Class of 2020
Texas A&M Rangel
College of Pharmacy
prophylaxis education, mental health
monitoring, addressing health disparities in
communities, amongst others, prepares us
to be socially responsible and to become
better healthcare providers. Interprofessional
education and understanding the value
in each healthcare professional’s role in
public health serves not only the patient,
but the community at large.
The Official Publication of the Texas Society of Health-System Pharmacists – R&E Foundation

The Lone Star Pharmacist December 2018 Page 5
New
Practitioner
Testimonial
TSHP and Me
Justin D. Shanks,
PharmD
TSHP is a wonderful
organization to link people
together and a great outlet
for service. I have been
a member of TSHP since
my first year of pharmacy
school when I joined
the Texas A&M Rangel
College of Pharmacy
Student Society of Health-
System Pharmacy (SSHP).
Texas SSHP membership
includes membership in
a local chapter of healthsystem
pharmacy and TSHP; likewise, TSHP pharmacist
membership also includes membership in a local
chapter. This integral link connects local pharmacists,
pharmacy technicians, and pharmacy students not
only in their region, but also with like-minded pharmacy
professionals across the great state of Texas through
the TSHP community. The opportunity to connect with
health-system professionals in my local area and across
Texas has been of vital importance to me when I was
a student and now as a new practitioner pharmacist.
Local chapter involvement as a pharmacy student
allowed me to meet pharmacists and pharmacy
technicians in the Corpus Christi area outside of the
hospital that I worked at as a technician. These new
relationships helped me as a SSHP leader to strengthen
existing service learning experiences and attempt to
facilitate new programs for my fellow students at regional
hospitals and clinics. The exploration of these ideas
and ensuing conversations would have been that much
more difficult without the collaborative environment of
TSHP and the local chapters. Subsequently, these
and similar relationships in TSHP have allowed me
to introduce students and pharmacy leaders to similar
experiences.
SSHP and TSHP leadership service afforded me
a relatively unique experience to be involved as a
student representative on the TSHP Board of Directors.
These opportunities helped me not only serve TSHP by
providing student input on the Board, but also as an
opportunity for me to develop long-lasting relationships
with influential pharmacists, pharmaceutical industry
representatives, and pharmacy technician leaders.
I firmly believe that these relationships have not only
helped me grow personally and professionally, but
also in my search to secure a pharmacy residency
position and a job after residency. It may be said that
without these relationships with pharmacy leaders, I
would not be in the position that I am now.
While the opportunity to serve as a student
representative on the Board is reserved for the TSHP
student chair, there are similar opportunities for students,
new practitioner pharmacists, and experienced
pharmacists. Local chapter involvement, Pharmacist
New Practitioner’s Section, TSHP Membership Council,
TSHP Communication Council, or the TSHP Educational
Affairs Council are just some of the exciting possibilities
for membership involvement. Volunteer service in TSHP
not only provides an opportunity to work with and
learn from influential pharmacy leaders, but also to get
to know other pharmacy professionals across Texas.
TSHP has and continues to give me an opportunity to
serve my profession. I encourage pharmacy students,
technicians, and pharmacists alike to strongly consider
membership in TSHP and now it’s your turn! Will you
join the TSHP community today?
Make It Your New Year’s Resolution!
Hello fellow friends
of Pharmacy! I hope
everyone had a fantastic
Pharmacy Month in
October, a wonderful
time with family on
Thanksgiving, and now
wishing everyone the best
in this festive time as we
prepare to celebrate the
Christmas Holiday and
a New Year! Now that Jesse Chaffino
2018 is coming to a close,
what is there to look forward to in 2019? I know I’m
looking forward to the TSHP Annual Seminar!
Mark your April 12-14, 2019 on your new
calendar for the largest educational and networking
meeting of pharmacists, students, technicians, and
industry professionals in the state of Texas. With a
focus on quality patient care and medication safety,
pharmacist and technician registrants may select from
over 40 hours of programming. This past year’s event
at The Woodlands was a huge success and I can
tell you the TSHP leadership team has been working
TSHP
TSHP
hard ever since to make the 2019 event in Frisco, TX,
even better!
Registration is now open! And with early
registration comes Early Bird discounts. Want a
bigger discount? Join TSHP today and get exclusive
membership discounts. When you join the TSHP
community, you can enjoy all the additional resources
and benefits that come with membership AND you
also automatically become a member of your local
chapter, allowing you to take advantage of all the
benefits offered near you. Our local chapters have
seen significant growth in recent months, which means
there are a lot of great things happening at the local
level in your pharmacy community.
Make it your New Year’s Resolution! Become a
member and grow with TSHP. Get involved and be
a part of the #PharmacyStrong movement. Current
TSHP community members near you are already
taking advantage of what TSHP and the respective
local chapter has to offer. Visit www.tshp.org to
learn more about member benefits and registration
information for the 2019 TSHP Annual Seminar. Until
next time, enjoy the Holidays and we hope to see
you in Frisco, TX, in April!
Career Career Center Center
Connecting Talent
Connecting Talent
with Opportunity
with Opportunity
www.tshp.org/cc
www.tshp.org/cc
The Official Publication of the Texas Society of Health-System Pharmacists – R&E Foundation

Page 6 December 2018 The Lone Star Pharmacist
Pharmacy Management Corner Continued from pg. 3
Competition case study is under development and will be presented to
the MSEC for review, feedback, suggestions, and support. The MSEC
embraces and supports community initiatives like this and will continue to
provide aid throughout the year to this program and other ongoing TSHP
programs like the Mentorship Program, Member Recognition Program, and
student skills competition judging, as well as several new projects launching
in the coming months.
We look forward to working with and serving our fellow Pharmacy
Management professionals, the TSHP community, and the entire Texas
pharmacy community. Please contact me at tony.palmer@unthsc.edu, if
there is anything we can do for you.
Texas A&M Irma Lerma Rangel College of Pharmacy in Kingsville, Texas
Department Head of Pharmacy Practice
The Texas A&M Irma Lerma Rangel College of Pharmacy invites
applications for tenure track positions at the associate or full professor
level or tenured at the associate or full professor levels to serve as the
Department Head of Pharmacy Practice.
The college and this growing department of 30 faculty members is located
on the campuses of Texas A&M University-Kingsville and Texas A&M
University in College Station as well as at other strategic hubs including
Houston, Temple, Round Rock, Corpus Christi, and McAllen. For more
information about the college and the department, visit: http://pharmacy.
tamhsc.edu/.
The Department Head will be responsible for providing leadership,
direction, mentorship, and administrative oversight to faculty and staff in
the Department of Pharmacy Practice. The successful candidate will be
involved in engaging faculty teaching in an integrated curriculum and will
be responsible for ensuring that department members create and sustain
excellence in teaching, research/scholarship, and practice. Additionally,
s/he will help develop, manage and oversee faculty practice plans, and
will also engage in interprofessional activities across the institution’s other
colleges/schools and with external organizations.
Essential duties and responsibilities of the position include:
• demonstrating a commitment to academic excellence;
• recruiting and retaining faculty and staff;
• setting goals with faculty members in the form of planned annual activity and faculty
development;
• and representing the department to the university, community, and external stakeholders.
The successful candidate will leverage the department’s resources, including the
vibrant and committed faculty, to advance the mission, vision, and goals of the
department and the college. The Department Head reports directly to the Dean and
is a member of the college’s Executive Committee.
Applicants should have an earned Pharm.D. or Ph.D. degree; be residency trained
or equivalent; be eligible for pharmacist licensure in the state of Texas; possess
excellent interpersonal and communication skills; demonstrate proven leadership
and management abilities; good scholarship and publication record; have a
minimum five years in a leadership or management role; and a demonstrated
commitment to diversity and inclusion.
Salary for this position is very competitive and commensurate with education and
experience, and with excellent fringe benefits. Review of applications will begin
immediately and continue until the position is filled. Interested candidates are
invited to submit a letter of interest, a statement of accomplishments and interests,
a current curriculum vita, and a list of four references to Maria Jaramillo, Executive
Assistant to the Dean: jaramillo@tamhsc.edu. Informal inquiries are also welcome.
The Texas A&M System is an Equal Opportunity/Affirmative Action/Veterans/Disability Employer committed to diversity.
TSHP Calendar
of Events
December 2018
December 1
December 2
December 11
December 16
December 2018
December 2018
January 2019
January 15
January 31
February 2019
February 1
February 2
February 6
February 25
March 2019
March 15
March 21
April 2019
April 1
April 10-11
April 12-14
TSHP Annual Seminar and Alcalde registration opens
Texas Reception at ASHP Midyear Meeting – Anaheim, CA
TSHP Nomination Day (www.tshp.org/nomday)
TSHP Annual Member Recognition
Awards submission deadline
TSHP R&E Foundation Poster Competition submissions opens
TSHP R&E Foundation Scholarship applications open
TSHP Leadership Challenge entry deadline
TSHP Annual Seminar and Alcalde Early
Bird Registration deadline
TSHP R&E Foundation Scholarship application deadline
Metroplex Society of Health System
Pharmacists (DFW) Annual Seminar
Texas State Board of Pharmacy Board
Business Meeting (Austin, TX)
TSHP R&E Foundation Poster Competition entry deadline
TSHP Clinical Skills & Disease State Management
Competitions registration deadline
TSHP Annual Seminar Room Block Reservation Deadline
TSHP Annual Seminar and Alcalde Advance
Online Registration deadline
Alcalde Southwest Leadership Conference (Frisco, TX)
TSHP Annual Seminar (Frisco, TX)
The Official Publication of the Texas Society of Health-System Pharmacists – R&E Foundation

The Lone Star Pharmacist December 2018 Page 7
FDA New Drugs • August ‘18 - October ‘18
Approval Date Drug Name Active Ingredients Submission Classification Review Priority ** Company
8/2/2018 TIGECYCLINENDA #211158 TIGECYCLINE Type 5 - New Formulation or New Manufacturer Standard AMNEAL PHARMS LLC
8/7/2018 ORKAMBINDA #211358 IVACAFTOR; LUMACAFTOR Type 3 - New Dosage Form Priority VERTEX PHARMS INC
8/8/2018 SOLUPREPNDA #208288 CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL Standard 3M HEALTH CARE
8/8/2018 JORNAY PMNDA #209311 METHYLPHENIDATE HYDROCHLORIDE Type 3 - New Dosage Form Standard IRONSHORE PHARMS
8/8/2018 ARAKODANDA #210607 TAFENOQUINE SUCCINATE Type 5 - New Formulation or New Manufacturer Priority 60 DEGREES PHARMS
8/8/2018 POTELIGEOBLA #761051 MOGAMULIZUMAB-KPKC Type 5 - New Formulation or New Manufacturer KYOWA KIRIN
8/10/2018 GALAFOLDNDA #208623 MIGALASTAT HYDROCHLORIDE Type 1 - New Molecular Entity Priority AMICUS THERAPS US
8/10/2018 ANNOVERANDA #209627 ETHINYL ESTRADIOL; SEGESTERONE ACETATE Type 1 - New Molecular Entity Standard THERAPEUTICSMD INC
8/10/2018 ONPATTRONDA #210922 PATISIRAN SODIUM Type 1 - New Molecular Entity Priority ALNYLAM PHARMS INC
8/13/2018 LAMIVUDINE, NEVIRAPINE AND
ZIDOVUDINENDA #205626
LAMIVUDINE; NEVIRAPINE; ZIDOVUDINE Type 4 - New Combination Standard MICRO LABS
8/14/2018 CEQUANDA #210913 CYCLOSPORINE Type 5 - New Formulation or New Manufacturer Standard SUN PHARMA GLOBAL
8/15/2018 EFAVIRENZ, LAMIVUDINE AND TENOFOVIR
DISOPROXIL FUMARATENDA #0
EFAVIRENZ; LAMIVUDINE; TENOFOVIR
DISOPROXIL FUMARATE
Type 4 - New Combination Standard AUROBINDO PHARMA LTD
8/16/2018 LOPINAVIR; RITONAVIRNDA #210540 LOPINAVIR; RITONAVIR Type 5 - New Formulation or New Manufacturer Priority MYLAN LABS LTD
8/20/2018 DIACOMITNDA #206709 STIRIPENTOL Type 1 - New Molecular Entity Priority BIOCODEX SA
8/20/2018 DIACOMITNDA #207223 STIRIPENTOL Type 3 - New Dosage Form Priority BIOCODEX SA
8/22/2018 INVELTYSNDA #210565 LOTEPREDNOL ETABONATE Type 5 - New Formulation or New Manufacturer Standard KALA PHARMS INC
8/22/2018 OXERVATEBLA #761094 CENEGERMIN-BKBJ DOMPE FARMACEUTICI
8/23/2018 ALTRENONDA #209353 TRETINOIN Type 3 - New Dosage Form Standard DOW PHARM
8/23/2018 TAKHZYROBLA #761090 LANADELUMAB (SHP643) DYAX CORP.
8/24/2018 OXYGEN, USPNDA #212314 OXYGEN, USP Medical Gas Standard UNIVERSAL INDUSTRIAL GASES,
8/24/2018 NITROGEN, NFNDA #212315 NITROGEN, NF Medical Gas Unknown UNIVERSAL INDUSTRIAL GASES,
8/27/2018 XERAVANDA #211109 ERAVACYCLINE DIHYDROCHLORIDE Type 1 - New Molecular Entity Priority TETRAPHASE PHARMS
8/28/2018 LUTRATE DEPOT KITNDA #205054 LEUPROLIDE ACETATE Type 5 - New Formulation or New Manufacturer Standard GP-PHARM SA
8/30/2018 PIFELTRONDA #210806 DORAVIRINE Type 1 - New Molecular Entity Standard MSD MERCK CO
8/30/2018 DELSTRIGONDA #210807 DORAVIRINE; LAMIVUDINE; TENOFOVIR
DISOPROXIL FUMARATE
Type 4 - New Combination Standard MSD MERCK CO
9/5/2018 TIGLUTIK KITNDA #209080 RILUZOLE Type 3 - New Dosage Form Standard ITALFARMACO SPA
9/7/2018 CASSIPANDA #208042 BUPRENORPHINE HYDROCHLORIDE;
NALOXONE HYDROCHLORIDE
Type 5 - New Formulation or New Manufacturer Standard TEVA PHARMS USA
9/12/2018 XELPROSNDA #206185 LATANOPROST Type 3 - New Dosage Form Standard SUN PHARMA GLOBAL
9/13/2018 LUMOXITIBLA #761104 MOXETUMOMAB PASUDOTOX-TDFK ASTRAZENECA AB
9/14/2018 SEIZALAMNDA #209566 MIDAZOLAM HYDROCHLORIDE Type 10 - New Indication Submitted as Distinct NDA - Not Conso Standard MERIDIAN MEDCL TECHN
9/14/2018 AJOVYBLA #761089 FREMANEZUMAB-VFRM TEVA PHARMS USA
9/24/2018 COPIKTRANDA #211155 DUVELISIB Type 1 - New Molecular Entity Priority VERASTEM INC
9/27/2018 VIZIMPRONDA #211288 DACOMITINIB Type 1 - New Molecular Entity and Type 4 - New Combination Priority PFIZER INC
9/27/2018 EMGALITYBLA #761063 GALCANEZUMAB-GNLM ELI LILLY AND CO
9/28/2018 ARIKAYCE KITNDA #207356 AMIKACIN SULFATE Type 3 - New Dosage Form Priority INSMED INC
9/28/2018 XYOSTED (AUTOINJECTOR)NDA #209863 TESTOSTERONE ENANTHATE Type 3 - New Dosage Form Standard ANTARES PHARMA INC
9/28/2018 LIBTAYOBLA #761097 CEMIPLIMAB-RWLC REGENERON PHARMACEUTICAL
10/1/2018 SEYSARANDA #209521 SARECYCLINE Type 1 - New Molecular Entity Standard ALLERGAN INC
10/2/2018 NUZYRANDA #209816 OMADACYCLINE Type 1 - New Molecular Entity Priority PARATEK PHARMS INC
10/2/2018 NUZYRANDA #209817 OMADACYCLINE Type 1 - New Molecular Entity Priority PARATEK PHARMS INC
10/5/2018 JEMDELNDA #209355 HALOBETASOL PROPIONATE Type 3 - New Dosage Form Standard DOW PHARM
10/5/2018 TEGSEDINDA #211172 INOTERSEN Type 1 - New Molecular Entity Priority IONIS PHARMS INC
10/5/2018 REVCOVIBLA #761092 ELAPEGADEMASE-LVLR LEADIANT BIOSCI INC
10/12/2018 YUTIQNDA #210331 FLUOCINOLONE ACETONIDE Type 5 - New Formulation or New Manufacturer Standard EYEPOINT PHARMS
10/16/2018 TALZENNANDA #211651 TALAZOPARIB Type 1 - New Molecular Entity Priority PFIZER INC
10/19/2018 QMIIZ ODT (meloxicam) orally disintegrating
tablets, 7.5 and 15 mgNDA #2
MELOXICAM Type 3 - New Dosage Form Standard TERSERA THERAPS LLC
10/19/2018 KHAPZORYNDA #211226 LEVOLEUCOVORIN Type 2 - New Active Ingredient Standard SPECTRUM PHARMS
10/24/2018 XOFLUZANDA #210854 BALOXAVIR MARBOXIL Type 1 - New Molecular Entity Priority SHIONOGI INC
10/28/2018 BIJUVANDA #210132 ESTRADIOL;PROGESTERONE Type 4 - New Combination Standard THERAPEUTICSMD INC
10/30/2018 HYRIMOZBLA #761071 ADALIMUMAB-ADAZ SANDOZ INC
** 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 Official Publication of the Texas Society of Health-System Pharmacists – R&E Foundation

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