Teva Confirms September PDUFA Date for Fremanezumab

Teva Confirms September PDUFA Date for Fremanezumab

Source: 
CP Wire
snippet: 

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) confirmed on 5/23/18 that the U.S. Food and Drug Administration (FDA) has extended the goal date of the Biologics License Application (BLA) for fremanezumab, an investigational therapy for the preventive treatment of migraine. The Prescription Drug User Fee Act (PDUFA) action date for fremanezumab is set for September 16, 2018. There are no additional data requests from the FDA.