Allergan Posurdex NDA by year end?
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Allergan plans to submit a macular edema NDA for Posurdex (dexamethasone) in late 2006 or early 2007, the company says May 3. The firm is highlighting less frequent dosing it says is possible with the extended-release drug delivery technology used in the proprietary dexamethasone formulation (1Pharmaceutical Approvals Monthly February 2006, p. 16). Allergan notes it also has completed preclinical studies of Posurdex in combination with anti-VEGF agents for treatment of macular degeneration. Genentech's VEGF agent Lucentis (ranibizumab) has a June 29 priority review user fee date for macular degeneration (2Pharmaceutical Approvals Monthly March 2006, In Brief)...