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UPDATE 2-Vivus says FDA accepts weight-loss drug application
November 3, 2011 / 4:41 PM / 6 years ago

UPDATE 2-Vivus says FDA accepts weight-loss drug application

* Says FDA assigns 5-month review period on marketing application

* Says advisory committee to discuss application in Q1, 2012 (Adds background, context, details on competition, updates share movement)

Nov 3 (Reuters) - U.S. health regulators accepted Vivus Inc’s second attempt at filing for marketing approval of its weight-loss drug, and set a five-month review period.

The U.S. Food and Drug Administration set April 17, 2012 as the deadline to decide on the approval of the drug, Qnexa, setting a definite time frame for the pill to hit pharmacy shelves.

In October 2010, the FDA had denied approval for Qnexa and asked for evidence that higher heart rate associated with the drug does not increase the risk of major heart problems.

FDA’s acceptance of the marketing application puts the Mountain View, California-based company ahead of its peers -- Arena Pharmaceuticals Inc and Orexigen Therapeutics Inc -- in the race to get their fat-fighting drug approved.

The regulator also said that data on the drug submitted under the application will be reviewed by an advisory committee in the first quarter of 2012.

Shares of Vivus, which have gained about 30 percent in value in the last three months, were trading down 1 percent at $9.37 on Thursday afternoon on Nasdaq. Arena and Orexigen shares remained flat on Nasdaq. (Reporting by Vidya L Nathan in Bangalore; Editing by Saumyadeb Chakrabarty and Gopakumar Warrier)

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