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