Teva Pharmaceutical Industries Ltd. said the U.S. Food and Drug Administration extended the target action date of its biologics license application for migraine drug fremanezumab.
The FDA plans to take an action on the application for fremanezumab by Sept. 16. The drug regulator did not request any additional data.
Fremanezumab is an investigational therapy being reviewed as a quarterly or monthly injection for preventing migraine in adults.
The Israeli generic-drug maker is racing against rivals in developing a similar class of migraine drugs, including Eli Lilly and Co.'s galcanezumab and Amgen Inc. and Novartis AG's Aimovig.
