Whistle-Blower Complaint Delayed Approval of Savella

Allegations from a whistle-blower regarding the integrity of the clinical study data supporting Forest Laboratories’ NDA for fibromyalgia drug Savella delayed agency approval of the product for nearly three months. The resulting for-cause inspection in December was successful, and the drug was approved Jan. 14 under a REMS program that requires a MedGuide.
Drug Industry Daily