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U.S. Department of Health and Human Services

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Approval of zidovudine water-dispersible tablets, 100 mg for pediatrics/adults unable to swallow tablets

On February 23, 2011, the Food and Drug Administration (FDA) granted approval for zidovudine tablets, 100 mg, indicated for use in combination with other antiretrovirals for the treatment of HIV-1 infection. The tablets are intended for pediatric use and can be dispersed in water for all patients unable to swallow tablets.

The tablets are manufactured by Matrix Laboratories Limited of Hyderabad, India.

This product will not be marketed in the United States, where the oral syrup formulation serves pediatric dosing needs.

Zidovudine is a Nucleoside Reverse Transcriptase Inhibitor (NRTI) anti-viral drug indicated for use in combination with other antiretroviral agents for the treatment of HIV-1 infection.

The application was reviewed under expedited review provisions for the President’s Emergency Plan for AIDS Relief (PEPFAR).
 

A list of all FDA approved and tentatively approved antiretrovirals for PEPFAR can be found on the FDA web site.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration