ARTICLE | Clinical News

Tesamorelin regulatory update

July 26, 2010 7:00 AM UTC

Theratechnologies said that it now expects an FDA decision on an NDA for tesamorelin next quarter. The application, which originally had a PDUFA date of July 27, is under review for excess abdominal fat in HIV-infected patients with lipodystrophy. According to Theratechnologies, FDA said it needs more time to complete the review, but did not provide a reason why. ...