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Theratechnologies Reveals FDA Review Date For Tesamorelin New Drug Application - Quick Facts

Theratechnologies (TH.TO) said the U.S. Food and Drug Administration has confirmed that the Endocrinologic and Metabolic Drugs Advisory Committee will meet to review Theratechnologies' New Drug Application for tesamorelin on February 24, 2010. The meeting will take place at the Hilton Washington DC/Silver Spring.

Theratechnologies submitted an NDA to the FDA on May 29, 2009, for tesamorelin, an analogue of the growth hormone releasing factor proposed for the treatment of excess abdominal fat in HIV patients with lipodystrophy. The FDA filed the NDA on August 12, 2009, which initiated a substantive review of the application. The Prescription Drug Fee Act date, which is the target date for the FDA to complete its review of tesamorelin NDA, is March 29, 2010.

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