Cellegesic
nitroglycerin ointment, 0.4%
Treatment for Anal FissuresCellegy Reports Status of Response Date for FDA Review
BRISBANE, Calif., June 30, 2005 -- Cellegy Pharmaceuticals, Inc. announced that it has been informed by the U.S. Food and Drug Administration that the FDA is still reviewing the Company's recently submitted amended New Drug Application (NDA) for Cellegesic (0.4% nitroglycerin ointment), for the treatment of pain associated with chronic anal fissure. The Company expects the agency to respond soon after its review is completed.
About Cellegy
Cellegy Pharmaceuticals is a specialty biopharmaceutical company
that develops and commercializes prescription drugs for the
treatment of women's health care conditions, including reduction in
the transmission of HIV and sexual dysfunction, gastrointestinal
disorders and certain cancers.
Related Articles:
FDA Issues Approvable Letter to Cellegy Pharmaceuticals for Cellegesic - July 10, 2006
Cellegy Reports Review by Advisory Committee April 2006 - January 9, 2006
Cellegy Reports New FDA Target Response Date of June 15 - May 5, 2005
Cellegy Responds to FDA Inquiries Concerning Cellegesic - April 18, 2005
FDA Issues Not Approvable Letter for Cellegesic - December 23, 2004
Cellegesic Granted Priority Review by FDA - October 14, 2004
NDA for Cellegesic is Accepted for Review by FDA - September 1, 2004
Cellegy Submits NDA for Cellegesic to Treat Chronic Anal Fissure Pain - June 30, 2004
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