PALONOSETRON HYDROCHLORIDE | N021372 | HELSINN HEALTHCARE SA
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Helsinn Healthcare S.A. et al v. Baxter Healthcare Corporation 2 patentsANDA 206916palonosetron hydrochloride | D. Del. | 2018-10-25 | Terminated 2019-08-05 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Fresenius Kabi USA, LLC FDA-2018-P-4664 · 4 docket documents Fresenius Kabi USA, LLC filed this citizen petition requesting that the FDA designate its Palonosetron Hydrochloride Injection approved under 505(b)(2) NDA 208109 as therapeutically equivalent with an AP rating to the reference listed drug Aloxi (Palonosetron Hydrochloride Injection, NDA 021372) by | 505(q) | 2018-12-10 | Withdrawn | Fresenius Kabi USA, LLC |
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-1721 · 7 docket documents Helsinn Healthcare SA, represented by Hogan Lovells US LLP, filed this citizen petition under Section 505(q) of the Food, Drug, and Cosmetic Act regarding Cipla Limited's ANDA 206396 for a generic version of ALOXI (palonosetron hydrochloride) Injection. Helsinn requests that FDA require Cipla to sub | 505(q) | 2015-05-18 | Denied | Hogan Lovells US LLP (Helsinn) |
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) |
Lachman Consultant Services, Inc. - Citizen Petition FDA-2012-P-0458 · 4 docket documents Lachman Consultant Services, Inc. filed this petition requesting that the FDA determine whether Aloxi (palonosetron hydrochloride) Capsules, 0.5 mg, approved under NDA 22-233, was voluntarily withdrawn or withheld from sale for safety or effectiveness reasons pursuant to 21 CFR 314.161 and 314.162, | 505(q) | 2012-05-10 | Granted | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
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