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For Consumers

Tentative approval of lamivudine and tenofovir df fixed dose combination tablets, 300mg/300mg

On November 5, 2009, using expedited review procedures developed to support the President's Emergency Program For AIDS Relief (PEPFAR), the Food and Drug Administration (FDA), granted tentative approval for lamivudine and tenofovir disoproxil fumarate fixed dose combination tablets, 300mg/300mg.

The fixed dose combination product, indicated for use in combination with other antiretrovirals for the treatment of HIV-1 infection, is manufactured by Hetero Drugs Limited of Hyberdad, India.

FDA's tentative approval of this product means that while FDA cannot fully approve the product for sale in the United States because of existing patent protections, it has been shown to meet all of FDA's safety, efficacy and manufacturing quality standards. Tentative approval qualifies the product for purchase using PEPFAR funds.

Fixed dose combination products like this one can help ease pill burden and simplify therapy, and may help increase adherence to therapeutic regimens, potentially reducing development of resistance to the separate drugs. Fixed dose combination products can help also help reduce costs associated with treatment for HIV infection.

Lamivudine and tenofovir df are Nucleoside Reverse Transcriptase Inhibitors (NRTIs).

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

Page Last Updated: 08/20/2014
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