HIV/AIDS Update - Tentative approval of lamivudine and tenofovir disoproxil fumarate Tablets, 300 mg/300 mg

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: HIV/AIDS Update - Tentative approval of lamivudine and tenofovir disoproxil fumarate Tablets, 300 mg/300 mg

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 Friday, May 17, 2013, FDA granted tentative approval for a fixed-dose formulation of lamivudine and tenofovir disoproxil fumarate tablets, 300 mg/300 mg) for use in combination with other antiretrovirals for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older and weighing at least 35 kg. 

"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.

Made by Ranbaxy Laboratories Limited of Gurgaon, India, the review was conducted 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, intended to encourage sponsors to submit applications for combination and co-packaged products, and to facilitate submission of such applications to FDA.

Lamivudine and tenofovir disoproxil fumarate belong to the class of antiretroviral drugs known as Nucleoside Reverse Transcriptase Inhibitors (NRTIs).

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

If you are interested in receiving information about a broader range of FDA topics, consider subscribing to the FDA Patient Network News, a twice monthly newsletter containing FDA-related information on a variety of topics, including new product approvals, significant labeling changes, safety warnings, notices of upcoming public meetings, proposed regulatory guidances and opportunity to comment, and other information of interest to patients and patient advocates.

FDA has also launched a new patient focused web site called the Patient Network, designed to provide patients and patient advocates with easily accessible information about what FDA does, and how they can have a bigger voice in regulatory issues that affect patients.

---

This email was sent to list-fda@xxxxxxxxxxx using GovDelivery, on behalf of: U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420