logo
Plus   Neg
Share
Email

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 RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Quick Facts

Editors Pick
A $716 billion defense policy bill easily cleared the Senate on Monday, although the legislation must still be reconciled with the version previously approved by the House. The Senate voted 85 to 10 in favor of the National Defense Authorization Act, which authorizes U.S. military spending for fiscal 2019. Voip-Pal.com Inc. has filed a lawsuit against Amazon Inc., accusing Alexa's calling and messaging services of infringing its patents. The lawsuit, filed by Voip-Pal in the U.S. District Court in Nevada, accuses Amazon's Alexa calling and messaging system of using Voip-Pal's patented technologies to direct voice/video calls and voice messages to both Amazon subscribers and non-subscribers. Canada is a step closer to becoming the first G-7 nation to legalize marijuana nationwide after the House of Commons voted to allow recreational use. The bill will now go back to the country's Senate, which had already approved a version of the bill. On Monday, the House of Commons voted 205 to 82 in favor of the Bill C-45, known as the Cannabis Act.
Follow RTT