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U.S. Department of Health and Human Services

For Consumers

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Tentative approval of lamivudine and tenofovir disoproxil fumarate Tablets, 300 mg/300 mg

On Friday, May 17, 2013, FDA granted tentative approval for a fixed-dose formulation of lamivudine and tenofovir disoproxil fumarate tablets, 300 mg/300 mg, for use in combination with other antiretrovirals for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older and weighing at least 35 kg. 

"Tentative approval" means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but is not eligible for marketing in the U.S. because of existing patent protections. Tentative approval does, however, make the product eligible for purchase outside the United States under the PEPFAR program.
 
Made by Ranbaxy Laboratories Limited of Gurgaon, India, the review was conducted under the FDA guidance titled Fixed Dose Combinations, Co-Packaged Drug Products, and Single-Entity Versions of Previously approved Antiretrovirals for the Treatment of HIV, intended to encourage sponsors to submit applications for combination and co-packaged products, and to facilitate submission of such applications to FDA.
 
Lamivudine and tenofovir disoproxil fumarate belong to the class of antiretroviral drugs known as Nucleoside Reverse Transcriptase Inhibitors (NRTIs).
A complete list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan is available on the FDA web site.
 
Richard Klein
Office of Health and Constituent Affairs
Food and Drug Administration

Kimberly Struble
Division of Antiviral Products
Food and Drug Administration

Steve Morin
Office of Health and Constituent Affairs
Food and Drug Administration