FDA sets PDUFA date for Zogenix' Sumavel

Zogenix, a private US specialty pharmaceutical company, says that the Food and Drug Administration has provided a target date of July 15 for  completion of its review of the New Drug Application for Sumavel DosePro  (sumatriptan injection) needle-free delivery system. Zogenix is seeking  to market the product for the acute treatment of migraine attacks with  or without aura, and the acute treatment of cluster headache episodes.

In October, the company received a Complete Response letter from the FDA  citing the need for a single additional in vitro test to be conducted.  Zogenix recently submitted this information to the agency, which has  accepted this as a complete response, providing the new Prescription  Drug User Fee Act review date of July 15.