Cellegy Cellegesic NDA withdrawn
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Cellegy withdraws NDA for nitroglycerin ointment Cellegesic following a meeting with FDA "during which it became clear the agency would require additional information in order to grant marketing clearance," the company reports April 26. The firm will continue to discuss with FDA requirements for approval, which could include additional clinical studies. The NDA was seeking approval for pain associated with chronic anal fissure
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