Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

For Consumers

Tentative approval of generic emtricitabine capsules

On May 9, 2008, FDA granted tentative approval for a generic formulation of emtricitabine capsules, 200 mg, manufactured by Aurobindo Pharma Limited, Hyberdad, India, for use in combination with other antiretrovirals in the treatment of HIV infection.  The application was reviewed under expedited review provisions for the President’s Emergency Plan for AIDS Relief (PEPFAR), and represents the first tentative approval of a generic formulation of emtricitabine.

 "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 and/or exclusivity rights. Tentative approval does, however, make the product eligible for consideration for purchase outside the United States under the PEPFAR program.

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 tentative approval is for a generic version of Emtriva Capsules, 200 mg, marketed by Gilead Sciences Inc., a Nucleoside Reverse Transcriptase Inhibitor (NRTI).  Emtriva is subject to existing patent protections and pediatric exclusivity extensions. Effective patent dates can be found in the agency's publication titled Approved Drug Products with Therapeutic Equivalence Evaluations, also known as the "Orange Book"

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

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

Page Last Updated: 08/12/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.