RectivTreatment for Anal Fissure and Fistula
Update: Rectiv (nitroglycerin ointment) Now FDA Approved - June 21, 2011
Cellegy 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.
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.
Posted: June 2005
- ProStrakan Receives FDA Approval for Rectiv for the Treatment of Moderate to Severe Pain Associated With Chronic Anal Fissures - June 22, 2011
- 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