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FDA approves two separate generic drug treatments for HIV-1 infection
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The FDA granted tentative approval of a generic formulation of atazanavir sulfate capsules and approved a generic fixed-dose formulation of lamivudine and zidovudine tablets, both indicated for use combined with other antiviral agents for the treatment of HIV-1 infection, according to a news release.
The new formulation of atazanavir sulfate capsules (100 mg, 150 mg and 300 mg) is a generic version of Reyataz capsules (Bristol-Myers Squibb). The fixed-dose formulation of lamivudine (150 mg) and zidovudine (300 mg) tablets is the therapeutic equivalent of Combivir tablets (GlaxoSmithKline). Both generic treatments are manufactured in India.
The tentative approval of atazanavir sulfate for use in combination therapy means the treatment is not yet available for marketing in the United States due to existing patient protections, although the treatment has met all of the required quality, safety and efficacy standards of the FDA. The application was reviewed under the expedited review provisions of the President’s Emergency Plan for AIDS Relief, or PEPFAR.