Aurobindo receives tentative FDA approval for HIV-1 fixed dose combination tablet

By Lisa Kerner

Charlotte, N.C., July 3 - Aurobindo Pharma Ltd said received tentative Food and Drug Administration approval of its New Drug Application for the fixed dose combination drug product Lamivudine plus Zidovudine plus Nevirapine Tablets for the treatment of HIV-1 infection.

The tablet comprises two-nucleoside reverse transcriptase inhibitor and a non-nucleoside reverse transcriptase inhibitor for use as a first-line therapy.

This is the first NDA generic approval for a three-drug combination in the $4.5 billion market, according to a company news release.

Aurobindo is a Hyderabad, India-based pharmaceutical company.

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