FDA approves generic combo HIV- 1 drug
The FDA has approved a generic version of the combination lamivudine and zidovudine tablets for the treatment of HIV-1 infection, according to an FDA press release.
The 150 mg and 300 mg tablets will be manufactured by Aurbindo Pharma Limited of Hyderabad, India and is indicated for use in combination with other antiretroviral therapies for the treatment of HIV-1.
The FDA has determined that the generic is bioequivalent and therapeutically equivalent to the reference drug (Combivir, GlaxoSmithKline). The approval means that the generic formulation may be marketed in the United States, according to the release.