Alexza Announces Extension of the ADASUVE PDUFA Goal Date by Three Months
Alexza Pharmaceuticals, Inc. (Nasdaq: ALXA) announced today that the U.S. Food and Drug Administration will require additional time to complete its review of the New Drug Application for ADASUVE™ (Staccato® loxapine).
In a notice received from the FDA, the Prescription Drug User Fee Act (PDUFA) date for the ADASUVE NDA has been extended from February 4, 2012 to May 4, 2012.
The FDA notified Alexza that its January 10, 2012 submission to the NDA, updating the proposed Risk Evaluation and Mitigation Strategy (REMS) program, has been designated as a major amendment. The FDA exercised its option to extend the PDUFA goal date to provide time to complete the review when a sponsor submits materials the FDA considers a major amendment to an NDA within three months of the PDUFA goal date. Alexza has submitted this amendment to the NDA, among others, to address topics discussed during the December 12, 2011 Psychopharmacologic Drugs Advisory Committee meeting on the ADASUVE application.
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