Organon Implanon contraceptive "approvable" again
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Organon receives a second "approvable" letter for its implantable contraceptive Implanon. Although FDA initially deemed the etonogestrel sub-dermal implant approvable in November 2004, the agency has continued to request additional information, Organon said. The original user fee date was in October 2004. The firm plans to meet with FDA to address outstanding issues associated with the review...