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For Consumers

FDA approval of generic zidovudine injection, 10 mg/mL

On April 6, 2010, FDA granted approval to a generic formulation of zidovudine injection USP, 10 mg/mL, packaged in 200 mg/20 mL single-use vials, manufactured by Pharmaforce, Inc., of Columbus, OH.  FDA has determined that  the generic formulation is bioequivalent and, therefore, therapeutically equivalent to the reference listed drug, Retrovir® IV Infusion, 10 mg/mL, of VIIV Healthcare Co.

Approval of this generic formulation means that it may be marketed in the United States.  A list of approved generic formulations of antiretroviral drugs used in the treatment of HIV infection is available at

Richard Klein
Office of Special Health Issues
Food and Drug Administration

Kimberly Struble
Division of Antiviral Drug Products
Food and Drug Administration

Page Last Updated: 08/21/2014
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