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news.FDA has confirmed that the Endocrinologic and Metabolic Drugs Advisory Committee will meet to review Theratechnologies' New Drug Application (NDA) for Tesamorelin on Wednesday, February 24, 2010.
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Theratechnologies, a Canadian biopharmaceutical company with core expertise in peptide-based therapeutics, has said that the meeting will take place at the Hilton Washington DC/Silver Spring (8727 Colesville Road, Silver Spring, Maryland).
The company submitted an NDA for Tesamorelin to the FDA on May 29, 2009. Tesamorelin is 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 (PDUFA) date, which is the target date for the FDA to complete its review of Tesamorelin NDA, is March 29, 2010.