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Treatment for Anal Fissure and Fistula

Update: Rectiv (nitroglycerin ointment) Now FDA Approved - June 21, 2011

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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