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Alexza extends Adasuve PDUFA goal date by three months

Monday, January 23, 2012 12:56 PM

The FDA will require additional time to complete its review of the New Drug Application (NDA) for Adasuve (Staccato loxapine), according to Alexza Pharmaceuticals.

In a notice received from the FDA, the Prescription Drug User Fee Act (PDUFA) date for Alexza’s Adasuve NDA has been extended from Feb. 4, 2012 to May 4, 2012.

The FDA notified Alexza that its Jan. 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 exercises 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 submitted the amendment to the NDA, among others, to address topics discussed during the Dec. 12, 2011 Psychopharmacologic Drugs advisory committee meeting on the Adasuve application.

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