Cellegy's Cellegesic to be reviewed by FDA advisory committee in April

By Angela McDaniels

Seattle, Jan. 9 - Cellegy Pharmaceuticals Inc. said Cellegesic (0.4% nitroglycerin ointment) will be reviewed by the Food and Drug Administration's Cardio-Renal Advisory Committee on April 25.

The FDA issued a not approvable letter in December 2004 in response to the company's New Drug Application for Cellegesic. Cellegy said it resubmitted an amended New Drug Application containing new analyses to the FDA in April 2005.

Cellegesic, branded Rectogesic outside the United States, is approved and is being marketed in the United Kingdom by ProStrakan for the treatment of pain associated with chronic anal fissures. A similar formulation of Rectogesic is being sold in Australia, New Zealand, Singapore and South Korea.

Cellegy is a specialty biopharmaceutical company based in Huntingdon Valley, Pa., that develops and commercializes prescription drugs for the treatment of women's health care conditions.

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