• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

For Consumers

  • Print
  • Share
  • E-mail

Tentative approval of generic efavirenz, emtricitabine and tenofovir disoproxil fumarate tablet

On October 31, 2013, FDA granted tentative approval for a generic formulation of efavirenz, emtricitabine and tenofovir disoproxil fumarate tablet, 600 mg/ 200 mg/ 300 mg, a fixed-dose combination of 2 nucleoside analog HIV-1 reverse transcriptase inhibitors and 1 non-nucleoside HIV-1 reverse transcriptase inhibitor, indicated for use alone as a complete regimen or in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults and pediatric patients 12 years ofage and older, made by Hetero Labs Limited of Hyderabad, India.

The application was reviewed under the expedited review provisions of the President’s Emergency Plan for AIDS Relief (PEPFAR).

"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.

This is a generic version of Atripla tablets, a product of Gilead Sciences.

Patent information for all approved drugs is available in the FDA Approved Drug Products with Therapeutic Equivalence Evaluations, commonly referred to as the Orange Book.

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