FDA Tentatively Approves Fixed-dose Lamivudine/zidovudine

Editor Melinda Young, Senior Managing Editor Gary Evans, and Executive Editor Coles McKagen report no relationships with companies related to this field of study. Physician Reviewer Morris Harper, MD, AAHIVS, Vice President, Chief Medical Officer, HIV/AIDS & Hepatitis Associates, Waynesburg, PA, reports consulting work with Agouron Pharmaceuticals, Gilead Sciences, Abbott Pharmaceuticals, GlaxoSmithKline, and Bristol-Myers Squibb. Nurse Planner Kay Ball, RN, PhD, MSA, CNOR, FAAN
Perioperative Consultant/Educator, K & D Medical, Lewis Center, OH, is a consultant and stockholder with Steris Corp. and is on the speaker's bureau for the Association of periOperative Nurses.

This article originally appeared in the December 2010 issue of AIDS Alert.

On Oct. 18, 2010, the FDA granted tentative approval to fixed-dose combination lamivudine/zidovudine tablets, 150 mg/300 mg, indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults. The product is manufactured by Strides Arcolab Limited of Bangalore, India. The application was reviewed under expedited review provisions for the President's Emergency Plan for AIDS Relief (PEPFAR).

Combination products such as this one can decrease pill burden and may result in improved dosing compliance for HIV-infected individuals.

"Tentative approval" means that FDA has concluded that a drug product meets all required quality, safety and efficacy standards, but is not presently eligible for final approval for marketing in the United States because of existing patents and/or exclusivity rights. However, tentative approval does make the product eligible for purchase and use outside the United States under PEPFAR.

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 is a generic formulation of Combivir tablets, 150 mg/300 mg, a product of VIIV Healthcare Company, which is subject to patent protection in the United States.

A list of all Approved and Tentatively Approved Antiretrovirals in Association with the President's Emergency Plan is available on the FDA website.