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# HIV/AIDS Update - Tentative approval of efavirenz, lamivudine and tenofovir disoproxil fumarate tablets, 600 mg/300 mg/300 mg
- URL: https://www.foodconsumer.org/hiv_aids_update_0814140746/
- Published: 2014-08-14T20:44:00.000Z
- Updated: 2026-09-22T16:32:54.000Z
- Description: FDA granted Macleods Pharmaceuticals tentative approval for a fixed-dose efavirenz, lamivudine and tenofovir disoproxil fumarate tablet for HIV-1 in adults and adolescents over 16 weighing at least 40 kg. Patents bar U.S. marketing, but it qualifies for purchase abroad under PEPFAR.
- Author: Food Consumer
- Tags: Miscellaneous, Health News, #vivvo-import

On August 14, 2014, FDA granted tentative approval for a fixed-dose combination consisting of efavirenz, lamivudine and tenofovir disoproxil fumarate tablets, 600 mg/300 mg/300 mg, for use alone or in combination with other antiretrovirals for the treatment of HIV-1 infection in adults and adolescents greater than 16 years of age and weighing at least 40 kg.

The application was filed by Macleods Pharmaceuticals Limited of Mumbai, India.

"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.

The application was reviewed under the expedited review provisions of the President’s Emergency Plan for AIDS Relief ([PEPFAR](http://www.pepfar.gov/?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery)).

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](http://www.fda.gov/InternationalPrograms/FDABeyondOurBordersForeignOffices/AsiaandAfrica/ucm119231.htm?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery).

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