Intelence Approval History

  • FDA approved: Yes (First approved January 18th, 2008)
  • Brand name: Intelence
  • Generic name: etravirine
  • 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.

FDA Approval History for Intelence

DateArticle
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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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