Quick Facts
FONT-SIZE Plus   Neg
Share SHARE

VIVUS Says FDA Extends Qnexa PDUFA Date

RELATED NEWS
Trade VVUS now with 

VIVUS Inc. (VVUS: Quote) 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.

Click here to receive FREE breaking news email alerts for VIVUS INC and others in your portfolio

by RTT Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
South Korea announced a $11.4 billion stimulus plan to stimulate the economy, which logged its slowest growth in more than a year on weak private spending. The finance ministry announced policy financing support for small businesses and to boost household income. The ministry increased the lending ceiling for businesses to $15 billion from $10 billion. European stocks are seen flat to slightly lower on Thursday amid a lack of cues to sustain two days of gains. Geopolitical concerns remain and the earnings season is picking up pace, rendering investor mood cautious. In economic releases, investors eye PMI reports from major European economies and... Social networking giant Facebook, Inc. said Wednesday after the markets closed that its second quarter profit more than doubled from last year, as revenue surged 61% amid strong growth in mobile advertising. The company's quarterly earnings per share, excluding items, also came in above analysts' expectations as did its quarterly revenue.
comments powered by Disqus
FREE Newsletters, Analysis & Alerts

 

Stay informed with our FREE daily Newsletters and real-time breaking News Alerts. Sign up to receive the latest information on business news, health, technology, biotech, market analysis, currency trading and more.