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




 

Food and Drug Administration - February 24, 2011

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: http://www.pepfar.gov/).

A list of all FDA approved and tentatively approved antiretrovirals for PEPFARv [http://www.fda.gov/InternationalPrograms/FDABeyondOurBordersForeignOffices/AsiaandAfrica/ucm119231.htm] 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



 


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Information in this article was accurate in February 24, 2011. The state of the art may have changed since the publication date. This material is designed to support, not replace, the relationship that exists between you and your doctor. Always discuss treatment options with a doctor who specializes in treating HIV.