Depomed (DEPO)

[surf1944]

8:00AM DepoMed announces Serada NDA acceptance and FDA Advisory Committee Meeting (DEPO) 6.05 : Co announced that its New Drug Application (NDA) for Serada has been accepted for filing by the U.S. Food and Drug Administration (FDA). In addition, the FDA has informed the company that the FDA's Reproductive Health Drugs Advisory Committee will discuss the Serada NDA at an Advisory Committee meeting tentatively scheduled for March 4, 2013. The NDA will be subject to a standard review and will have a Prescription Drug User Fee Act (PDUFA) action date of May 31, 2013. The acceptance of the NDA reflects the FDA's determination that the application is sufficiently complete to permit a substantive review. The PDUFA date is the goal date for the FDA to complete its review of the NDA.