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
Athletic clothing company Under Armour has ended sponsorship of a female hunter after a video that showed her husband killing a bear caused an outrage. Sponsorship of Sarah Bowmar, the wife and hunting companion of US hunter Josh Bowmar, was dropped by Under Armor following the negative response to... The City of Somerville has decided not to appeal a key environmental permit granted in July for Wynn Resorts Ltd.'s $2.1 billion Everett casino project. The decision paves the way for work on the casino project, known as Wynn Boston Harbor, to go ahead. Apple Inc. is planning to launch three new iPhone models in 2017, including a premium handset with a curved display, the Nikkei Asian Review reported Monday, citing sources familiar with Apple's plans. The new iPhone models will reportedly include a 4.7-inch model, a 5.5-inch model and the premium handset that will be either 5.5 inches or larger.
comments powered by Disqus
Follow RTT