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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

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

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