FDA finds gepirone ER “not approvable” as a treatment for Major Depressive Disorder

The U.S. Food and Drug Administration has determined that Organon’s gepirone ER New Drug Application is “not approvable.”

This action is the FDA’s response to an amendment to Organon’s New Drug Application submitted to the FDA in December 2003. Organon plans to withdraw the application for gepirone as a treatment for major depressive disorder.

“Organon is disappointed in this response from the FDA and we are moving forward with our next steps in the development of products for mental health” said Toon Wilderbeek, Organon International President and Akzo Nobel Board Member.