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Anal Fissures
U.S. FDA issues not approvable letter for Cellegesic
January 25th, 2005
Cellegy Pharmaceuticals, Inc., (CLGY) announced that it received a communication from the U.S. Food and Drug Administration (FDA) in the form of a not approvable letter for its product Cellegesic (nitroglycerin ointment). Cellegesic was the subject of an NDA (new drug application) that was filed with the FDA for the treatment of pain associated with chronic anal fissures. In October the FDA granted the application a priority review status. K. Michael Forrest, Cellegy's president and CEO, stated, "We believe that our third phase III trial achieved the requirements for approval of Cellegesic as agreed with the FDA under the provisions of a special...
Source: Life Science Weekly (2005-01-25)
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