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Theratechnologies Says Positive Vote By FDA Advisory Committee For Tesamorelin - Quick Facts

Theratechnologies (TH.TO) said that the U.S. Food and Drug Administration Endocrinologic and Metabolic Drugs Advisory Committee recommended by a 16 to 0 unanimous vote that tesamorelin, a growth hormone releasing factor, should be granted marketing approval by the FDA for the treatment of excess abdominal fat in HIV-infected patients with lipodystrophy, based on a favorable benefit-risk profile. The FDA has indicated that the action goal date, which is the target date for the FDA to complete its review of the tesamorelin New Drug Application, would be July 27, 2010.

Tesamorelin is a novel, stabilized analogue of growth hormone releasing factor. GRF is a hypothalamic peptide that acts on the pituitary cells in the brain to stimulate the synthesis and pulsatile release of endogenous growth hormone.

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