(Updates with closing shares in the fourth paragraph.)
Oct. 17 (Bloomberg) -- Vivus Inc. resubmitted its Qnexa obesity treatment for U.S. regulatory approval after updating the label to say the drug shouldn’t be used by women capable of having children.
Vivus is seeking clearance from the Food and Drug Administration for Qnexa as a treatment for obese or overweight patients with weight-related disorders such as high blood pressure or diabetes.
The FDA rejected Qnexa last October citing concerns the medicine may cause birth defects and increased heart rate. In addition to the label warning, the resubmission includes a risk evaluation and mitigation strategy, the Mountain View, California-based company said today in a statement.
Vivus was unchanged at $8.58 at 4 p.m.
The FDA will schedule an advisory panel in the first quarter of next year and a final decision on whether the drug is approved would come in the second quarter of 2012, Vivus said when it announced it would resubmit the application Sept. 15.
Vivus has been competing with San Diego-based Arena Pharmaceuticals Inc. and La Jolla, California-based Orexigen Therapeutics Inc. to sell the first new prescription diet pill in the U.S.
--Editors: Chris Staiti, Bruce Rule
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