Wednesday, December 24, 2008

HIV/AIDS Update - Tentative approval of generic emtricitabine capsule formulation

You are receiving this message as a subscriber to the FDA HIV/AIDS electronic list serve. The purpose of the list serve is to relay important information about HIV/AIDS-related products and issues, including product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings and alerts to proposed regulatory guidances for comment.

Please do not reply to this message.

On December 23, 2008, FDA granted tentative approval for a generic version of emtricitabine capsules 200 mg, manufactured by Matrix Laboratories, Ltd., of Hyderabad, India, reviewed under the expedited review provisions for the President’s Emergency Plan for AIDS Relief (PEPFAR). Emtricitabine is a Nuceloside Reverse Transcriptase Inhibitor (NRTI) indicated in combination with other antiretroviral medications for teatment of HIV infection.

"Tentative approval" means that FDA has concluded that a drug product has met the required quality, safety and efficacy standards, but is not eligible for marketing in the U.S. because of existing patents and/or exclusivity rights. Tentative approval, however, does make the product eligible for consideration for purchase under the PEPFAR program.

This tentative approval is for a generic formulation of Emtriva Capsules, 200 mg made by Gilead Sciences, Inc., which is subject to patent protection and pediatric exclusivity. 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"

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

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 


Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@govdelivery.com.

This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).

GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

Post a Comment
Related Posts Plugin for WordPress, Blogger...

Popular Posts