FDA approves Vivus' weight loss drug

FDA approved late Tuesday an NDA for Qsymia from Vivus Inc. (NASDAQ:VVUS) for chronic weight management. The fixed-dose combination of phentermine and topiramate is indicated for adults with a BMI of 30 kg/m2 or greater, or adults with a BMI of 27 kg/m2 or greater who have at least one weight-related condition. Qsymia will be available in 4Q12.

Qsymia is contraindicated in pregnant women. The label states that women of childbearing age should have a negative pregnancy test before starting Qsymia and every month while taking the drug. Qsymia's label also says the drug should be discontinued in patients who fail to lose 5% of body weight after 12 weeks of treatment with the maximum daily dose of 15 mg/92 mg. Qsymia is not recommended in patients with recent or unstable heart disease or stroke. ...