Vivus Inc. Oct. 28 announced that it has received a complete response letter from the Food and Drug Administration regarding its new drug application for the weight loss drug Qnexa (phentermine/topiramate) controlled-release capsules.
In the letter, FDA said that the NDA cannot be approved in its present form. The application seeks the approval to market Qnexa as an oral, once-a-day formulation for the treatment of obesity, including weight loss and maintenance of weight loss, in patients who are obese or overweight with co-morbidities such as hypertension, type 2 diabetes, dyslipidemia, or central adiposity.
Vivus said FDA requested a comprehensive assessment ...
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