The Longest Review: Asclera’s Cosmetic Use Brought Strict Scrutiny
Executive Summary
The 64.7-month time span from Chemische Fabrik Kreussler’s submission of the Asclera (polidocanol) NDA to its approval is three years longer than the review time of any other CDER novel approval in 2010, but the spider vein treatment is an outlier in other ways too.
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