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U.S. Department of Health and Human Services

For Consumers

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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 http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/HIVandAIDSActivities/ucm118944.htm

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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