AEGiS-FDA: Approval of zidovudine 60 mg tablets for pediatric dosing Food and Drug AdministrationImportant note: Information in this article was accurate in 2009. The state of the art may have changed since the publication date.
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Approval of zidovudine 60 mg tablets for pediatric dosing

Food and Drug Administration - July 23, 2009
Richard Klein & Kimberly Struble

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
090723
FD090704

SOURCE: Food and Drug Administration (FDA).

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