Skip to Content

Dutrebis Approval History

  • FDA approved: Yes (First approved February 6th, 2015)
  • Brand name: Dutrebis
  • Generic name: lamivudine and raltegravir
  • Dosage form: Tablets
  • Company: Merck & Co., Inc.
  • Treatment for: HIV Infection

Dutrebis (lamivudine and raltegravir) is a fixed-dose combination of a nucleoside analog reverse transcriptase inhibitor and an integrase strand transfer inhibitor for the treatment of HIV-1 infection. Dutrebis will NOT be made commercially available in the U.S. at this time.

Development History and FDA Approval Process for Dutrebis

DateArticle
Feb 10, 2015Approval FDA Approves Dutrebis (lamivudine and raltegravir) for HIV-1 Infection
Jun 24, 2014FDA Accepts Merck’s NDA for Fixed-Dose Combination of Raltegravir with Lamivudine

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.

Hide