The FDA approved pirtobrutinib for untreated chronic lymphocytic leukemia, granted priority review to elinzanetant for breast cancer hot flashes, and more.
|Articles|March 9, 2011
- December 2010
- Volume 4
- Issue 12
FDA Requests Label Change for Generic Docetaxel
Author(s)OBTN
The FDA has requested that the generic drug manufacturer Hospira change the planned label for its generic formulation of docetaxel.
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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.
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