Fabre-Kramer Pharmaceuticals Inc. was able to convince FDA to change its mind about the adequacy of the data supporting the antidepressant Travivo (gepirone extended-release) and is now on the path to resubmitting its NDA.
The company announced on March 17 that FDA Office of New Drugs Director John Jenkins had decided that the Travivo data support efficacy of the drug for treatment of major depressive disorder (MDD)
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