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Cellegy Pharmaceuticals, Inc.
NDA for Cellegesic is accepted for review by U.S. FDA
September 24th, 2004
Cellegy Pharmaceuticals, Inc., announced that the U.S. Food and Drug Administration (FDA) has accepted for review the company's new drug application (NDA) for Cellegesic (nitroglycerin ointment) for the treatment of pain associated with chronic anal fissures. The FDA has established May 1, 2005 as the outside date for a decision on approvability of the product for commercial sale in the United States. Scheduling of clinical site audits by the FDA is already underway. K. Michael Forrest, Cellegy's president and CEO, said, "We are excited by this positive, but not unexpected, development. We have demonstrated in 3 phase III clinical trials that...
Source: Food & Drug Law Weekly (2004-09-24)
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