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Intelence Approval History

  • FDA approved: Yes (First approved January 18th, 2008)
  • Brand name: Intelence
  • Generic name: etravirine
  • Dosage form: Tablets
  • Previous name: TMC125
  • Company: Tibotec Pharmaceuticals Ltd.
  • Treatment for: HIV Infection

Intelence (etravirine) is a non-nucleoside reverse transcriptase inhibitor (NNRTI) for the treatment of human immunodeficiency virus type 1 (HIV-1) infection.

Development History and FDA Approval Process for Intelence

Mar 27, 2012Approval FDA Approves Intelence (etravirine) Tablets for Treatment-Experienced Pediatric Patients with HIV-1, Following Priority Review
Jan  3, 2011Approval FDA Approves New Dosage Strength for Intelence
Dec  2, 2009Approval U.S. Food And Drug Administration (FDA) Grants Traditional Approval for Intelence (etravirine)
Jan 22, 2008Approval FDA Approves Intelence (etravirine) for HIV Combination Therapy
Sep 20, 2007FDA Accepts New Drug Application for Priority Review of Investigational HIV Treatment TMC125
Jul 18, 2007New Drug Application for Investigational HIV Treatment TMC125 Submitted to U.S. Food and Drug Administration

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