FDA actions in brief, December 2009 (Zirgan, Welchol, Sculptra Aesthetic, Berinert, Crestor, Agriflu, Byetta)
Recent FDA approvals (through December 2009) related to Zirgan, Welchol, Sculptra Aesthetic, Berinert, Crestor, Agriflu, and Byetta.
Ganciclovir ophthalmic gel (Zirgan, Sirion Therapeutics) 0.15% was approved for acute herpetic keratitis (dendritic ulcers).
Colesevelam HCl (Welchol, Daiichi Sankyo) was approved for LDL-cholesterol lowering in pediatric patients with heterozygous familial hypercholesterolemia.
Injectable poly-L-lactic acid (Sculptra Aesthetic, Sanofi-aventis) was approved for the correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles.
Rosuvastatin (Crestor, AstraZeneca) was approved for lowering cholesterol in children and teens with heterozygous familial hypercholesterolemia that is characterized by high LDL cholesterol levels.
Seasonal influenza virus vaccine (Agriflu, Novartis Vaccines, Diagnostics) was approved for people ages 18 years and older to prevent disease caused by influenza virus subtypes A and B.
Exenatide (Byetta, Amylin Pharmaceuticals) was approved for use as a stand-alone medication along with diet and exercise to improve glycemic control in adults with type 2 diabetes.
David Calabrese of OptumRx Talks Top Three Drugs in Pipeline, Industry Trends in Q2
July 1st 2020In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.
Listen
