AMAG gets FDA warning for misbranding drugs
The FDA has sent a letter to the CEO of AMAG Pharmaceuticals Inc., warning the company that websites promoting two FDA-approved products omit information about risks associated with the drug products. The regulator says the omissions amount to a misbranding of the drugs, in violation of FDA rules.
One of the products in question is Feraheme, an iron replacement therapy for patients with kidney disease, that was approved in July of 2009. The other is GastroMARK, which is a diagnostic tool for oral use with magnetic resonance imaging to enhance the delineation of the bowel to distinguish it from organs and tissues that are adjacent to the upper regions of the gastrointestinal tract.