Journal Ad for Watson’s Anemia Drug Misleading, FDA Says in Untitled Letter

The Food and Drug Administration has told Watson Pharmaceuticals Inc. that a journal ad for Nulecit (sodium ferric gluconate complex in sucrose injection) is misleading because it presents unsubstantiated claims, according to an “untitled” letter posted recently on FDA’s website.

Nulecit, which is the generic version of the Sanofi drug Ferrlecit, is indicated for the treatment of iron deficiency anemia in adults patients and in pediatric patients age six years and older undergoing chronic hemodialysis who are receiving supplemental epoetin therapy.

The drug is contraindicated in all anemias not associated with iron deficiency, as well as in patients with hypersensitivity ...