Opportunity
Federal Register #FDA-2026-P-3104
FDA Regulatory Determination on CABAZITAXEL (cabazitaxel) Solution (Injection) 60 mg/6 mL (10 mg/mL)
Posted
August 26, 2026
Identifier
FDA-2026-P-3104
This notice from the Food and Drug Administration (FDA), under the Department of Health and Human Services, provides a regulatory determination regarding CABAZITAXEL (cabazitaxel) solution (injection), 60 mg/6 mL (10 mg/mL): - The FDA has determined that CABAZITAXEL (cabazitaxel) solution (injection), 60 mg/6 mL (10 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. - The drug is the subject of NDA 207970, held by Actavis LLC, an indirect subsidiary of Teva Pharmaceuticals USA, Inc. - This determination allows the FDA to approve abbreviated new drug applications (ANDAs) for generic versions of Cabazitaxel solution (injection), 60 mg/6 mL (10 mg/mL), provided all other legal and regulatory requirements are met. - The drug is indicated for use in combination with prednisone for the treatment of metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing regimen. - No evidence was found suggesting withdrawal for safety or effectiveness reasons, and the drug will remain listed in the Discontinued Drug Product List for reasons other than safety or effectiveness. - OEMs mentioned: Actavis LLC and Teva Pharmaceuticals USA, Inc. - This notice does not request procurement of products or services; it is a regulatory determination only.
Description
The Food and Drug Administration (FDA) has determined that CABAZITAXEL (cabazitaxel) solution (injection), 60 mg/6 mL (10 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination allows FDA to approve abbreviated new drug applications (ANDAs) for this drug if all other legal and regulatory requirements are met. The drug is indicated for treatment of metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing regimen. The determination follows a citizen petition and review of relevant data and records.