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 · 4 docket documents 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 | 505(q) | 2022-08-31 | Partially Denied | HBT Labs, Inc. |
Citizen Petition from Mediscovery, Inc. FDA-2006-P-0342 · 3 docket documents Mediscovery, Inc. filed this citizen petition under Section 505(j)(2)(C) of the FDC Act requesting permission to submit an abbreviated new drug application for Paclitaxel at a strength of 0.1 pM for aerosol administration, differing from the reference listed drug Taxol in both strength and route of | Other | 2008-12-12 | Open | Mediscovery, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
No patent or exclusivity listings for this strength.