AEGiS-FDA: Approval of generic foscarnet sodium Food and Drug AdministrationImportant note: Information in this article was accurate in 2005. The state of the art may have changed since the publication date.
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Approval of generic foscarnet sodium

Food and Drug Administration - May 31, 2005
Richard Klein


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.

Richard Klein, HIV/AIDS Program Director Office of Special Health Issues

Food and Drug Administration


050531
FD050504


SOURCE: Food and Drug Administration (FDA).

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