Rectiv
Generic name: nitroglycerin
Treatment for: Anal Fissure and Fistula
Cellegy Reports Review by Advisory Committee April 2006
HUNTINGDON VALLEY, Pa., January 9, 2006 -- Cellegy Pharmaceuticals, Inc. today announced that its discussions with the U.S. Food and Drug Administration regarding the Company's resubmitted New Drug Application (NDA) for Cellegesic (0.4% nitroglycerin ointment) have resulted in a review by the Cardio-Renal Advisory Committee. The review is scheduled for April 25, 2006.
Cellegesic, for the treatment of anal fissures, was the subject of an FDA Not Approvable letter in December 2004. An amended NDA, containing new analyses, was resubmitted to the FDA in April 2005 and has been under review at the FDA since then.
"We are happy that our Cellegesic NDA is being reviewed by the Advisory Committee in April," stated Richard C. Williams, Chairman and interim CEO. "We look forward to presenting our case and to the results of the Committee's review."
Posted: January 2006
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- FDA Issues Approvable Letter to Cellegy Pharmaceuticals for Cellegesic - July 10, 2006
- Cellegy Reports Status of Response Date for FDA Review - June 30, 2005
- Cellegy Reports New FDA Target Response Date of June 15 - May 5, 2005
- Cellegy Responds to FDA Inquiries Concerning Cellegesic - April 18, 2005
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- Cellegesic Granted Priority Review by FDA - October 14, 2004
- NDA for Cellegesic is Accepted for Review by FDA - September 1, 2004
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Rectiv (nitroglycerin) FDA Approval History
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