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U.S. Department of Health and Human Services

For Consumers

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Approval of zidovudine 60 mg tablets for pediatric dosing

On July 23, 2009, FDA granted approval for zidovudine 60 mg scored tablets for pediatric use, manufactured by Aurobindo Pharma Limited of Hyderabad, India. The application was reviewed under expedited review provisions for the President’s Emergency Plan for AIDS Relief (PEPFAR). 

This 60 mg tablet is an alternate formulation to oral syrup for pediatric use, and facilitates distribution and storage in settings where weight can negatively affect shipping/distribution, and high temperatures can shorten product shelf life. 

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.

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration