HIV/AIDS Update - Tentative approval of lamivudine and tenofovir DF 300 mg/300 mg fixed-dose combination

-Drugs@FDA Data Files

On January 7, 2011, the Food and Drug Administration (FDA) granted tentative approval for lamivudine and tenofovir DF Fixed Dose Combination Tablets, 300mg/300mg, indicated in combination with other antiretrovirals for the treatment of HIV-1 infection in adults and pediatric patients 12 years old and older.

"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 consideration for purchase outside the United States under the PEPFAR program [U.S. President's Emergency Plan for AIDS Relief].

As with all generic applications, FDA conducts an on-site inspection of each manufacturing facility, and of the facilities performing the bioequivalence studies, to evaluate the ability of the manufacturer to produce a quality product and to assess the quality of the bioequivalence data supporting the application prior to granting approval or tentative approval to these applications.

This fixed-dose combination product, combining two Nucleoside Reverse Transcriptase Inhibitors (NRTIs), is manufactured by Aurobindo Pharma Limited of Hyberdad, India.

This product was reviewed for PEPFAR 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 [http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM079742.pdf]developed to clarify what regulatory requirements apply to such applications, what issues might be of concern, and how these issues 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.

A list of all FDA approved and tentatively approved antiretrovirals for PEPFAR can be found on the FDA web site [Africa, Asia and the Pacific > President's Emergency Plan for AIDS Relief].

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration