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Approval of generic foscarnet sodium for treatment of CMV retinitis
FDA issued an approval on May 31, 2005 for a generic formulation of foscarnet sodium injection, 24 mg/mL, 250 mL and 500 mL single-dose containers, manufactured by Pharmaforce, Inc., of Columbus, Ohio. The product is indicated for the treatment of CMV retinitis in patients with acquired immunodeficiency syndrome (AIDS), making a generic alternative formulation available in the United States.
The product is a generic version of Foscavir (foscarnet sodium Injection) 24 mg/mL, 250 mL and 500 mL single-dose containers, manufactured by Astra Zeneca, originally approved in 1991.
HIV/AIDS Program Director
Office of Special Health Issues
Food and Drug Administration