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
President Barack Obama sought to emphasize in remarks on Wednesday that the American forces being deployed as part of the fight against the terrorist group ISIS will not have a combat mission. While buying interest has remained somewhat subdued, stocks continue to see modest strength in mid-day trading on Wednesday. The Dow has pulled back off its new record intraday high but remains in positive territory. Republican Joni Ernst has moved into the lead in the potentially crucial Iowa Senate race, according to the results of a Quinnipiac University poll released on Wednesday. The poll found that 50 percent of likely Iowa voters would support Ernst if the election were held today, while 44 percent would vote for Democratic Rep. Bruce Braley.
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.