Drug Development

U.S. FDA issues Approvable Letter to Cellegy Pharmaceuticals for Cellegesic

Published in Medical Letter on the CDC and FDA, August 13th, 2006

Cellegy Pharmaceuticals, Inc. (CLGY.OB) announced that it recently received a communication from the U.S. Food and Drug Administration in the form of an Approvable Letter for its product, Cellegesic (nitroglycerin ointment).

The letter stated, however, that before the company's New Drug Application (NDA) may be approved and the product approved for marketing, Cellegy must conduct another clinical trial to demonstrate efficacy at a level deemed statistically significant by the agency. The letter indicated that the agency was requiring an additional study because it believed the results of the three trials conducted to date did not provide substantial evidence that the...

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Source: Medical Letter on the CDC and FDA (2006-08-13)

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