FDA Requests Label Change for Generic Docetaxel

Publication
Article
Oncology & Biotech NewsDecember 2010
Volume 4
Issue 12

The FDA has requested that the generic drug manufacturer Hospira change the planned label for its generic formulation of 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.

Related Videos
Stephen V. Liu, MD
A panel of 5 experts on lung cancer
A panel of 5 experts on lung cancer
Video 6 - "Shared Decision Making and Multidisciplinary Collaboration in the Evolving HR+/HER2- Early-Stage Breast Cancer Landscape"
Manmeet Singh Ahluwalia, MD
John Paul Diaz, MD
Keiichi Fujiwara, MD, PhD, Saitama Medical University International Medical Center
D. Ross Camidge, MD, PhD
D. Ross Camidge, MD, PhD
Rita Nanda, MD