The Food and Drug Administration (FDA, Agency, or we) has determined that CABAZITAXEL (cabazitaxel) solution (injection), 60 milligrams (mg)/6 milliliters (mL) (10 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for Cabazitaxel (cabazitaxel) solution (injection), 60 mg/6 mL (10 mg/mL), if all other legal and regulatory requirements are met.
US Federal Register - FDA Notices · August 26, 2026
Determination That CABAZITAXEL Solution (Injection), 60 Milligrams/6 Milliliters, Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
Original title: Determination That CABAZITAXEL (Cabazitaxel) Solution (Injection), 60 Milligrams/6 Milliliters (10 Milligrams/Milliliter), Was Not Withdrawn From Sale for Reasons of Safety or Effectiveness
FDA determined cabazitaxel solution was not withdrawn for safety or effectiveness reasons, enabling ANDA approvals.
Published by US Federal Register - FDA Notices. HealthSignal links to the original document; the summary above is extracted from the source text.