The drug has been approved as a treatment for anemia in adults and children six years of age or older, undergoing chronic hemodialysis who are receiving supplemental epoetin therapy.
Nulecit is generic version of Sanofi-Aventis’ Ferrlecit.
In a bioequivalence study involving 240 healthy volunteers, Nulecit and Ferrlecit demonstrated comparable concentrations of total serum iron and transferrin-bound iron over 36 hours.
Watson Pharma Global Brands executive vice president Fred Wilkinson said Nulecit offers the nephrology community a value brand that is bioequivalent to the innovator product, with the added convenience of packaging in glass vials.
In 2009 Watson and GeneraMedix entered into a license agreement for the exclusive US marketing rights to Nulecit, which will be marketed by Watson’s Global Brands business.