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Egrifta Approval History

  • FDA approved: Yes (First approved November 10th, 2010)
  • Brand name: Egrifta
  • Generic name: tesamorelin
  • Dosage form: Injection
  • Company: Theratechnologies
  • Treatment for: Reduction of Excess Abdominal Fat in HIV-Infected Patients with Lipodystrophy

Egrifta (tesamorelin) is a synthetic analogue of growth hormone releasing factor (GRF) for the treatment of excess abdominal fat in HIV patients with lipodystrophy.

Development History and FDA Approval Process for Egrifta

Nov 11, 2010Approval FDA Approves Egrifta (tesamorelin for injection): First and Only Treatment for the Reduction of Excess Abdominal Fat in HIV-infected Patients with Lipodystrophy
Jul 22, 2010Theratechnologies: Update on timeline for FDA Action Date
Jun  7, 2010Theratechnologies announces positive vote by FDA Advisory Committee for tesamorelin
Mar 22, 2010FDA Confirms Date for Advisory Committee Review of the Tesamorelin New Drug Application
Feb 25, 2010Theratechnologies Announces a Tentative New Date for the FDA Advisory Committee Review of the tesamorelin New Drug Application
Nov  5, 2009Theratechnologies' NDA for Tesamorelin to be Reviewed by an FDA Advisory Committee
Aug 12, 2009U.S. Food And Drug Administration Has Accepted To File Theratechnologies' New Drug Application for tesamorelin
Jun  3, 2009Theratechnologies Files a New Drug Application for Tesamorelin With the US Food and Drug Administration

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