FDA OKs Cabazitaxel Generics After Safety Check
Published Date: 8/26/2026
Notice
Summary
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that CABAZITAXEL (cabazitaxel) solution (injection), 60 milligrams (mg)/6 milliliters (mL) (10 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness.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.
Analyzed Economic Effects
1 provisions identified: 1 benefits, 0 costs, 0 mixed.
Generic Cabazitaxel ANDA Approvals Allowed
FDA determined that CABAZITAXEL (cabazitaxel) solution (injection), 60 mg/6 mL (10 mg/mL), was not withdrawn from sale for reasons of safety or effectiveness. Because of that determination, FDA will allow Abbreviated New Drug Applications (ANDAs) that refer to this listed drug to be approved if they meet all other legal and regulatory requirements (NDA 207970 was initially approved March 14, 2024; the sponsor notified FDA of discontinuation on September 6, 2024; a citizen petition was filed March 24, 2026).
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