Ranbaxy Laboratories gets tentative approval for HIV combination therapy

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The US Food and Drug Administration has granted tentative approval for a fixed dose formulation of two generic drugs for use in combination with antiretrovirals.

Lamivudine and tenofovir disoproxil fumarate tablets, manufactured by India’s Ranbaxy Laboratories, will not be available for marketing in the US because of existing patent protections, but will be eligible for purchase elsewhere under the President’s Emergency Plan for Aids Relief programme.

lamuvudine

Lamivudine (2′,3′-dideoxy-3′-thiacytidine, commonly called 3TC) is a potent nucleoside analog reverse transcriptase inhibitor (nRTI).

It is marketed by GlaxoSmithKline with the brand names Zeffix, Heptovir, Epivir, and Epivir-HBV.

Lamivudine has been used for treatment of chronic hepatitis B at a lower dose than for treatment of HIV. It improves the seroconversion of e-antigen positive hepatitis B and also improves histology staging of the liver. Long term use of lamivudine unfortunately leads to emergence of a resistant hepatitis B virus (YMDD) mutant. Despite this, lamivudine is still used widely as it is well tolerated.

tenofovir disoproxil fumarate

Tenofovir disoproxil fumarate (TDF or PMPA), marketed by Gilead Sciences under the trade name Viread, belongs to a class of antiretroviral drugs known as nucleotide analogue reverse transcriptase inhibitors (NRTIs), which block reverse transcriptase, a crucial virus enzyme in human immunodeficiency virus 1 (HIV-1) and hepatitis B virus infections.