PDUFA goal date for Alexza's Adasuve extended, as Public Citizen says drug should not be approved

25 January 2012

US drug firm Alexza Pharmaceuticals (Nasdaq: ALXA) says that the US Food and Drug Administration will require additional time to complete its review of the New Drug Application for its antipsychotic drug candidate Adasuve (Staccato loxapine).

The news follows a positive advisory committee recommendation for the drug, albeit with a narrow vote of nine to eight, with one abstention (The Pharma Letter December 15, 2011). In a notice received from the FDA, the Prescription Drug User Fee Act (PDUFA) date for the Adasuve has been extended from February 4, 2012 to May 4, 2012.

REMS program viewed as major amendment

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK



Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Pharmaceutical