FDA Requests Label Change for Generic Docetaxel

The FDA has requested that the generic drug manufacturer Hospira change the planned label for its generic formulation of docetaxel, which is currently being considered for FDA approval. The change is needed because Hospira’s version of the drug will be supplied in two 10-mg/mL vials, rather than in a single 20-mg/mL vial, which the FDA has said sanofi-aventis is permitted to use when selling Taxotere, its branded version of docetaxel.