PACLITAXEL | N211875 | AMERICAN REGENT INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Abraxis BioScience, LLC v. HBT Labs, Inc. 12 patentspaclitaxel protein-bound particles for injectable suspension | D. Del. | 2018-12-19 | Terminated 2020-02-11 | — |
ABRAXIS BIOSCIENCE, LLC et al v. HBT LABS, INC. 12 patentspaclitaxel protein-bound particles for injectable suspension | D.N.J. | 2018-12-17 | Terminated 2019-02-07 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from HBT Labs, Inc. FDA-2022-P-2075 HBT Labs, Inc. submitted this petition on August 30, 2022, requesting that the FDA assign a therapeutic equivalence evaluation code of "AP" in the Orange Book to its Paclitaxel Protein-Bound Particles for Injectable Suspension (Albumin-Bound), 100 mg/vial, approved under NDA 211875, to establish the | Other | 2022-08-31 | Denied | HBT Labs |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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