PALONOSETRON HYDROCHLORIDE | N207963 | HIKMA PHARMACEUTICALS LLC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Helsinn Healthcare S.A. et al v. Exela Pharma Sciences LLC et al 2 patentspalonosetron hydrochloride | D. Del. | 2014-12-01 | Terminated 2016-05-09 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Exela Pharma Sciences FDA-2018-P-1197 · 4 docket documents Exela Pharma Sciences filed this petition requesting that the FDA assign a therapeutic equivalence code of "AP" in the Orange Book for Exela's Palonosetron Hydrochloride Injection 0.125 mg/mL (2 mL vial) approved under NDA 207963, claiming the product is pharmaceutically and therapeutically equivale | Other | 2018-03-20 | Denied | Exela Pharma Sciences |
Citizen Petition from Hogan Lovells US LLP (Helsinn) FDA-2015-P-1722 · 14 docket documents Hogan Lovells US LLP, on behalf of Helsinn Healthcare SA, filed this citizen petition under Section 505(q) of the Food, Drug, and Cosmetic Act on May 13, 2015, requesting that FDA not approve Exela Pharma Sciences' 505(b)(2) NDA 207963 for a palonosetron hydrochloride injection product that referenc | 505(q) | 2015-05-18 | Denied | Hogan Lovells US LLP (Helsinn) |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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