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Dutrebis Approval History

FDA Approved: Yes (Discontinued) (First approved February 6, 2015)
Brand name: Dutrebis
Generic name: lamivudine and raltegravir
Dosage form: Tablets
Company: Merck
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 is NOT commercially available in the U.S.

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

Further information

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