« Return to News | Clinical Intelligence

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.

Share:          
CLINICAL TRIAL RESOURCES

Search:

NEWS ONLINE ARCHIVE

Browse by:

CWWeekly

December 17

Medici Global says its Alzheimer's Facebook page demonstrates the need for more early detection trials

Analysts: Expect more equity purchases of CROs in 2013

Already a subscriber?
Log in to your digital subscription.

Subscribe to CWWeekly.

The CenterWatch Monthly

January 2013

Parexel celebrates 30 years of change, growth
CRO's founder and chairman reflects on challenges of the past, present and future

Strategies for increasing patient diversity in trials
Sponsors look to improve racial, ethnic recruitment without going overseas

Already a subscriber?
Log in to your digital subscription.

Purchase the January issue.

Subscribe to The CenterWatch Monthly.

December 2012

Publicity, regulation tightening reins on use of KOLs
Debate rages over need to revamp how sponsors use, pay medical experts

Time may be right to makeover the investigator brochure
Size, complexity prevent critical document from being thoroughly read

Already a subscriber?
Log in to your digital subscription.

Purchase the December issue.

Subscribe to The CenterWatch Monthly.

JobWatch centerwatch.com/jobwatch

Featured Jobs

More Jobs

 

Copyright © 1995-2013 CenterWatch.