Gepirone ER “not approvable” for third time

Executive Summary

FDA deems Fabre-Kramer Pharmaceuticals' gepirone ER "not approvable" for treatment of adults with major depressive disorder, firm says Nov. 2. FKP submitted an amendment to the NDA for the potential first-in-class 5HT1a agonist in May with data that FDA requested in a 2004 "not approvable" notice received by then-licensee Organon. The drug was to be marketed by GlaxoSmithKline under an agreement inked by the companies in February. The partners said they are evaluating FDA's response "to determine appropriate next steps." FKP reacquired rights to gepirone ER from Organon in 2005. Organon had withdrawn its application for the drug after receiving two "not approvable" letters, in 2002 and 2004 (1"The Pink Sheet" June 28, 2004, In Brief)...