Organon to withdraw gepirone NDA
Executive Summary
Organon is planning to withdraw the NDA for its antidepressant gepirone ER following the receipt of a second "not approvable" letter from FDA June 23. The company submitted additional data in December 2003, and planned to market the drug as Variza. FDA's response likely relates to efficacy concerns, which were cited in the first "not approvable" letter in April 2002. Organon had been counting on gepirone (along with the contraceptive Implanon) as one of two major launches in 2004 (1"The Pink Sheet" April 26, 2004, p. 15)...