Label Changes May Smooth Qnexa, Intermezzo Approvals
By Catherine Shaffer
Friday, September 16, 2011
Transcept Pharmaceuticals Inc. and Vivus Inc. each have adjusted the proposed labeling of their respective products in response to FDA concerns, with the hope that more restrictive labels will allow the products to be approved. Transcept's Intermezzo (zolpidem tartrate sublingual tablets) for insomnia will carry a lower recommended dose for women and instructions detailing the safest use of the drug. Likewise, Vivus is adding labeling material for Qnexa (phentermine/topiramate) stating that the drug is contraindicated for women with childbearing potential.
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