logo
Share SHARE
FONT-SIZE Plus   Neg

VIVUS Says FDA Extends Qnexa PDUFA Date

VIVUS Inc. (VVUS) said Monday that the U.S. Food and Drug Administration has extended the Prescription Drug User Fee Act date for its review of the Qnexa New Drug Application by three months from April 17 to July 17, 2012.

On April 4, following the FDA's request, VIVUS submitted the Qnexa Risk Evaluation and Mitigation Strategy, which was considered a major amendment to the NDA. The submission consisted of proposed REMS materials.

Since the receipt date was within three months of the user fee goal date, the FDA is extending the Prescription Drug User Fee Act date by three months to provide time for a full review of the submission, the company noted.

The Qnexa NDA seeks approval for the treatment of obesity, including weight loss and maintenance of weight loss for obese patients with weight-related co-morbidities such as hypertension, type 2 diabetes or dyslipidemia.

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
Netflix offers a bunch of popular movies, Netflix originals, new TV shows, and documentaries in the month of December 2016, including the second season of the hit sitcom 'Fuller House' and 2016 blockbuster 'Captain America: Civil War', as all are getting ready for the holidays. SpaceX, the space transport company of Tech entrepreneur Elon Musk, is likely to launch its first Falcon 9 rocket since September's launchpad explosion on December 16. SpaceX's satellite launch customer Iridium Communications Inc. announced Thursday that its next-generation global satellite constellation, Iridium NEXT, will be launched on SpaceX's Falcon 9 rocket. Bank holding company Wells Fargo & Co., amid struggles to re-establish itself after the fake-account scandal, on Thursday said it has separated the roles of the Chairman and Chief Executive Officer formally, by amending the company's By-Laws. The amendment is also for the Chairman and Vice Chairman of the Board to be independent directors. The amendments were effective immediately.
comments powered by Disqus
Follow RTT