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.

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