MORRISTOWN, N.J.—Watson Pharmaceuticals Inc. announced July 29 a license agreement with GeneraMedix Inc., for the exclusive U.S. marketing rights to a generic version of Ferrlecit, a drug indicated for the treatment of iron deficiency anemia in hemodialysis patients receiving supplemental epoetin therapy.
GeneraMedix has an Abbreviated New Drug Application (ANDA) on file with the U.S. Food and Drug Administration for a sodium ferric gluconate complex in sucrose product that is packaged in a vial. The application is under expedited review with the FDA.
Under the terms of the agreement, GeneraMedix will supply the product to Watson, which will market, sell and distribute the product in the United States. Terms of the license agreement have not been disclosed.
Watson currently markets the brand product, Ferrlecit, under a supply and distribution agreement with Sanofi-Aventis. The Ferrlecit product rights return to Sanofi-Aventis on Dec. 31, 2009.
