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
Ciena Corp., a provider of communications networking solutions, on Thursday reported a turnaround to profit in the fourth quarter on higher revenues and lower expenses. However results for the quarter missed analysts' estimates. Looking ahead, the company forecast revenue for the first quarter of fiscal 2017 in line with analysts' expectations. Wearable fitness device maker Fitbit Inc. said it has acquired the assets of struggling smartwatch startup Pebble, including key personnel and intellectual property related to software and firmware development. The acquisition excludes Pebble's hardware products. Financial terms of the deal were not disclosed. Starbucks is teaming up with Pokémon Go, a location based augmented reality game, to turn its stores into PokéStops and Gyms, reports said. Further, the coffee giant reportedly would open Italian bakeries that serve pizza, with the first store expected to open in late 2017.
comments powered by Disqus
Follow RTT