Avanir
This article was originally published in The Tan Sheet
Executive Summary
Docosanol 10% cream NDA (20-941) deemed "approvable" by FDA in May 30 letter. Final approval is expected in the third quarter after minor labeling issues are worked out, Avanir President and CEO Gerald Yakatan, PhD, says during a June 1 conference call. A proposed Rx version of the cream initially was determined "not approvable" by FDA due to missing data from a European trial and labeling concerns. The cold sore product will be marketed by SmithKline Beecham under a licensing agreement with San Diego-based Avanir. The introduction of the docosanol cream, expected to occur roughly six months after labeling is approved, will give SB another avenue into the OTC market. So far, SB has been unsuccessful in its attempts to switch its Rx cold sore drug Denavir (penciclovir) to OTC status