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).
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
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