Originally scheduled for Wednesday, February 24, 2010, the meeting will be rescheduled due to an administrative delay at the FDA. The FDA informed Theratechnologies that the delay is entirely procedural and is not related to the Tesamorelin NDA. A new meeting date will be announced shortly in the Federal Register.
Theratechnologies has 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-infected patients with lipodystrophy.
Reportedly, the FDA has filed the NDA on August 12, 2009, which initiated a substantive review of the application. The Prescription Drug User Fee Act (PDUFA) date, which is the target date for the FDA to complete its review of Tesamorelin’s NDA, is March 29, 2010.