Watson Pharmaceuticals, Inc, a leader in generic and specialty branded pharmaceuticals, announced a license agreement with GeneraMedix, Inc, for the exclusive US marketing rights to a generic version of Ferrlecit (sodium ferric gluconate complex in sucrose injection), a drug indicated for the treatment of iron deficiency anaemia in haemodialysis patients receiving supplemental epoetin therapy.
GeneraMedix has an Abbreviated New Drug Application (ANDA) on file with the FDA 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 US. 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 December 31, 2009.
Watson Pharma is a global leader in the development and distribution of pharmaceuticals with a broad portfolio of generic products and a specialized portfolio of branded pharmaceuticals focused on Urology, Gynaecology and Nephrology (Medical).
GeneraMedix is a privately held pharmaceutical company specializing in difficult to develop and/or manufacture injectable products for the US hospital and specialty markets.