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news.Watson Pharmaceuticals is all set to launch Nulecit (sodium ferric gluconate complex in sucrose injection), following the US Food and Drug Administration (FDA) approval of its licensing partner GeneraMedix's new drug application.
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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.