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.
Lamivudine, which has been used for the treatment of chronic hepatitis B, is marketed by GlaxoSmithKline with the brand names Zeffix, Heptovir, Epivir, and Epivir-HBV.
Tenofovir, marketed by Gilead Sciences under the trade name Viread, belongs to a class of antiretroviral drugs known as nucleotide analogue reverse transcriptase inhibitors.
The FDA concluded that the products have met all required quality, safety and efficacy standards.
Last week, Ranbaxy Laboratories agreed to pay a record fine to settle a criminal and civil lawsuit related to drug safety.
Ranbaxy said its US subsidiary pleaded guilty to felony charges under the Food, Drug and Cosmetic Act, which prohibits adulterated drugs, and four felony counts of lying to the US Food and Drug Administration about how it tested drugs.
The firm has agreed to pay $500m in what the US government called the largest drug-safety settlement to date with a generic drug manufacturer.
Image: According to estimates by WHO and UNAIDS, 34 million people were living with HIV at the end of 2011.