BioCentury
ARTICLE | Company News

Second complete response for Levadex

April 17, 2013 12:11 AM UTC

Allergan Inc. (NYSE:AGN) said FDA issued a complete response letter for a resubmitted NDA for Levadex dihydroergotamine for the acute treatment of migraines in adults. The company said it has already addressed the main issues raised by FDA in the letter, including a facility inspection of a third-party manufacturer and the manufacturing process for the final filled canisters of Levadex. The company, which said it also received draft product labeling from the agency, said it expects the "next FDA action" to occur by year end but would not disclose details, including when it expects to resubmit the NDA.

Allergan gained rights to Levadex through its acquisition of Map Pharmaceuticals Inc. this year. Map resubmitted the NDA in October (see BioCentury Extra, Oct. 12, 2012). ...