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Tentative approval fixed dose lamivudine and tenofovir disoproxil fumarate

On November 8, 2012, FDA granted tentative approval for lamivudine and tenofovir disoproxil fumarate fixed-dose combination tablets, 300 mg/300 mg, indicated 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.

Lamivudine and tenofovir disoproxil fumarate are both nucleoside reverse transcriptase inhibitors.

The product is manufactured by Macleods Pharmaceuticals Limited of Mumbai, India, and was reviewed 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, developed to clarify the regulatory requirements that apply to such applications, possible issues of concern, and how they should be addressed. The guidance is intended to encourage sponsors to submit applications for combination and co-packaged products, and to facilitate submission of such applications to FDA.

"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.

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 Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

Page Last Updated: 08/22/2014
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