FDA issues complete response for Levadex

FDA issued a complete response letter for an NDA from Map Pharmaceuticals Inc. (NASDAQ:MAPP) for Levadex to treat migraines. According to Map, FDA asked the company to address CMC issues, as well as issues related to a recent facility inspection of a third party manufacturer. Map said FDA did not request additional clinical studies or identify any clinical safety or efficacy issues. Map plans to request a meeting with FDA to discuss the letter. Map was off $0.70 to $16.44 on Tuesday. ...