Publication

Article

Oncology & Biotech News

December 2010
Volume4
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.

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.

Articles in this issue
Medulloblastoma Subtypes Are Different Diseases
Medulloblastoma Subtypes Are Different Diseases
ASH 2010: CPX-351 Improves Response in Elderly Patients With Newly Diagnosed Acute Myeloid Leukemia
ASH 2010: Elotuzumab Highly Active in Patients With Advanced Myeloma
ASH 2010: Intensified R-ACVBP More Effective and More Toxic Than R-CHOP in Diffuse Large B-Cell Lymphoma
ASH 2010: Carfilzomib Shrinks Tumors in More Than One-Third of Pretreated Myeloma Patients
ASH 2010: Brentuximab Vedotin Produces High Response Rate in Relapsed or Refractory Hodgkin Lymphoma
ASH 2010: Bosutinib Shows Promise as First-line Treatment of Chronic Myelogenous Leukemia
ASH 2010: Multiple Benefits Observed for Bortezomib in Newly Diagnosed Myeloma Patients
FDA Green-Lights Phase III Trial for Drug-Eluting Microspheres in Liver Cancer
FDA Requests Label Change for Generic Docetaxel
FDA Considers Approval of Fusilev for Colorectal Cancer
Advisory Panel Discusses Expanded Indication for Avodart
FDA Approves Zactima
Effects of UV Radiation Are Cumulative
People in Britain Say Find Aliens, Cure Cancer
Related Videos
Ruth M. O’Regan, MD
Kathleen N. Moore, MD, MS
Steven H. Lin, MD, PhD
Anna Weiss, MD, associate professor, Department of Surgery, Oncology, associate professor, Cancer Center, University of Rochester Medicine
Haley M. Hill, PA-C, discusses the role of multidisciplinary management in NRG1-positive non–small cell lung cancer and pancreatic cancer.
Haley M. Hill, PA-C, discusses preliminary data for zenocutuzumab in NRG1 fusion–positive non–small cell lung cancer and pancreatic cancer.
Haley M. Hill, PA-C, discusses how physician assistants aid in treatment planning for NRG1-positive non–small cell lung cancer and pancreatic cancer.
Haley M. Hill, PA-C, discusses DNA vs RNA sequencing for genetic testing in non–small cell lung cancer and pancreatic cancer.
Haley M. Hill, PA-C, discusses current approaches and treatment challenges in NRG1-positive non–small cell lung cancer and pancreatic cancer.
Jessica Donington, MD, MSCR, Melina Elpi Marmarelis, MD, and Ibiayi Dagogo-Jack, MD, on the next steps for biomarker testing in NSCLC.
Related Content
Lung cancer, Image credit: Axel Kock – stock.adobe.com
November 20th 2024

Osimertinib Approaches EU Approval in Locally Advanced EGFR+ NSCLC After Chemoradiation

How to Apply Research Developments in ALK-Positive NSCLC: With Chandler Park, MD, and Tejas Patil, MD
October 16th 2024

How to Apply Research Developments in ALK-Positive NSCLC: With Chandler Park, MD, and Tejas Patil, MD

Zorifertinib for EGFR+ NSCLC With CNS Metastases | Image Credit: © Cornflakesei - stock.adobe.com
November 20th 2024

Zorifertinib Receives NMPA Approval for EGFR+ NSCLC With CNS Metastases

Updated VISION Trial Data Showcase the Efficacy of Tepotinib in MET + NSCLC: With Martin Dietrich, MD
October 7th 2024

Updated VISION Trial Data Showcase the Efficacy of Tepotinib in MET + NSCLC: With Martin Dietrich, MD

Lung Cancer
November 19th 2024

Subcutaneous Pembrolizumab Plus Chemo Meets Pharmacokinetic End Points in NSCLC

Breast Cancer
November 18th 2024

Data Continue to Help Shape CDK4/6 Inhibitor Selection, Sequencing in HR+ Breast Cancer