Organon Abandons Gepirone Following Second “Not Approvable” Letter
This article was originally published in The Pink Sheet Daily
Executive Summary
Company will withdraw NDA for the antidepressant, which it had planned to market as Variza. With Implanon, Organon has one potential 2004 launch remaining; other new products are not expected before 2006-2007
You may also be interested in...
Third Strike For Gepirone ER: Fabre-Kramer/GSK Antidepressant “Not Approvable” Again
Antidepressant received two FDA “not approvable” letters when it was licensed to Organon.
Third Strike For Gepirone ER: Fabre-Kramer/GSK Antidepressant “Not Approvable” Again
Antidepressant received two FDA “not approvable” letters when it was licensed to Organon.
Pfizer Ends Asenapine Collaboration With Organon
Akzo Nobel unit will continue development of the Phase III antipsychotic as company moves forward with separation of its coatings and chemical division from its pharma business.