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Gepirone ER "not approvable" for MDD

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Fabre-Kramer Pharmaceuticals/GlaxoSmithKline's potential first-in-class 5HT1a agonist gepirone extended release is "not approvable" for adults with major depressive disorder, the companies say Nov. 2. The NDA rejection is the third for the therapy, which was denied by FDA in 2002 and 2004 while it was licensed to Organon (1Pharmaceutical Approvals Monthly July 1, 2004, p. 26). FKP took the antidepressant back in 2005. The Houston firm inked a development and commercialization deal with GSK in February...
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