Press Release

Approval of Generic Formulation of Lamivudine and Zidovudine Tablets, 150 mg/300 mg

From U.S. Food and Drug Administration

May 25, 2011

On May 25, 2011, FDA granted approval for a generic formulation fixed dose combination of lamivudine and zidovudine tablets, 150 mg/300 mg, a two nucleoside analogue reverse transcriptase inhibitors, indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.

The tablets are manufactured by TEVA Pharmaceuticals USA.

FDA has determined that the generic formulation is bioequivalent and, therefore, therapeutically equivalent to the reference listed drug, Combivir Tablets, a product of VIIV Healthcare Company.

Approval of this generic formulation means that it may be marketed in the United States. A list of approved generic formulations of antiretroviral drugs used in the treatment of HIV infection can be found at www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ ucm118944.htm.

FDA Approval of Generic ARVs: Nevirapine and Combivir Now Off-Patent in the U.S.

Indian Pharmaceutical Company Receives Tentative Drug Approval Under PEPFAR

This article was provided by U.S. Food and Drug Administration. Visit the FDA's website to find out more about their activities and publications.

More on HIV Medications

More News on Combivir (AZT/3TC)

What Does 2015 Hold in Store for HIV Research?

Stop Scaring Younger Generations With Stigmatic Images of HIV/AIDS

10 Under-the-Radar HIV Stories From 2014

Thoughts on PrEP -- From the First Person Cured of HIV

Via Online Petition, an HIV-Positive Soldier Requests Justice

More >>

TheBody.com App

My Health Tracker

Medication and Health Reminders

Assess Your Risk for HIV

U.S. ASO Finder

The Body is a service of Remedy Health Media, LLC, 750 3rd Avenue, 6th Floor, New York, NY 10017. The Body and its logos are trademarks of Remedy Health Media, LLC, and its subsidiaries, which owns the copyright of The Body's homepage, topic pages, page designs and HTML code. General Disclaimer: The Body is designed for educational purposes only and is not engaged in rendering medical advice or professional services. The information provided through The Body should not be used for diagnosing or treating a health problem or a disease. It is not a substitute for professional care. If you have or suspect you may have a health problem, consult your health care provider.