* Says FDA assigns 5-month review period on marketing
* Says advisory committee to discuss application in Q1, 2012
(Adds background, context, details on competition, updates
Nov 3 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
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)