Login to Your Account

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.

To continue reading subscribe now to BioWorld Today

Learn More about BioWorld Today

Already a subscriber? Sign In or Buy now to activate your subscription