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
Shares of thyssenKrupp AG were gaining around 2 percent in the morning trading in Germany after the steel giant Thursday said it expects clearly positive net income and significantly higher adjusted EBIT, a key earnings metric, in fiscal 2018. This was after reporting higher adjusted EBIT, sales and order intake in its fiscal 2017, despite a net loss due to charges. Senator Lisa Murkowski, R-Alaska, has expressed support for repealing Obamacare's individual mandate, a key provision Senate Republicans are hoping to use to offset the cost of their tax reform bill. The Congressional Budget Office estimates repealing the requirement that nearly all Americans purchase... Automotive startup Divergent 3D said that a Chinese-led investment syndicate has agreed to commit up to $107 million in financing through a new investment round. Hong Kong-based investment holding company, O Luxe Holdings Limited, led the investment group, which includes Horizons Ventures, Shanghai Alliance Investment Limited and Altran Technologies.
comments powered by Disqus
Follow RTT