CABAZITAXEL | N207970 | ACTAVIS LLC AN INDIRECT WHOLLY OWNED SUB OF TEVA PHARMACEUTICALS USA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Sanofi-Aventis U.S. LLC, et al. v. Sandoz Inc. 2 patentsANDA 207736, 207619, 207718, 207591cabazitaxel | D. Del. | 2020-06-12 | Terminated 2023-07-05 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from ProPharma FDA-2026-P-3104 · 2 docket documents Amneal Pharmaceuticals Inc., through ProPharma, filed this citizen petition requesting that the FDA determine that CABAZITAXEL injection for intravenous use 60 mg/6 mL (10 mg/mL) under NDA 207970 held by Actavis LLC was not discontinued for reasons of safety or effectiveness, to permit Amneal to rel | 505(q) | 2026-03-25 | Open | ProPharma |
Citizen Petition from Anne A. Shirinian-Orlando FDA-2018-P-2749 · 4 docket documents Anne A. Shirinian-Orlando filed this petition under Section 355(e) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA issue strict dosage and administration guidelines for prostate cancer chemotherapy medications including Zytiga (abiraterone acetate), Jevtana (cabazitaxel), and Xta | Other | 2018-07-18 | Open | Anne A. Shirinian-Orlando |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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