LACOSAMIDE | N022254 | UCB INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2016-06-17 | Terminated 2018-09-20 | — | |
| N.D. Ill. | 2013-08-01 | Terminated 2013-09-16 | — | |
UCB Inc. et al v. Watson Laboratories Inc. - Florida et al 1 patentANDA 204855lacosamide | D. Del. | 2013-07-10 | Terminated 2016-09-02 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Citizen Petition from Nicholas J. Gardino FDA-2024-P-4164 · 5 docket documents Nicholas J. Gardino, an individual citizen and parent of a child with epilepsy, filed this petition to the DEA and FDA under Section 201 of the Controlled Substances Act and relevant CFR regulations, requesting that lacosamide be decontrolled from its current Schedule V classification. Gardino argue | Other | 2024-09-03 | Denied | Nicholas J. Gardino |
Suitability Petition Amendment from Newcastle Bioscience LLC FDA-2024-P-3293 · 11 docket documents Newcastle Bioscience LLC filed an amendment to its suitability petition for Lacosamide ODT, correcting the requested strength from 125 mg to 112.5 mg to align with the proposed labeling for consideration as suitable for ANDA filing. The amendment addresses an administrative error identified in the o | Suitability | 2024-08-01 | Granted | — |
Suitability Citizen Petition from RegCon Solutions LLC FDA-2022-P-0747 · 8 docket documents RegCon Solutions, LLC filed an ANDA suitability petition under Section 505(j)(2)(C) on May 5, 2022, requesting FDA approval to submit an abbreviated new drug application for Lacosamide Injection USP 100mg/10mL, a reduced-strength formulation of the referenced drug VIMPAT (lacosamide) injection 200mg | Suitability | 2022-05-06 | Granted | RegCon Solutions LLC |
Attachment A Package Insert of Reference List Drug (Vimpat ®) re Suitability ... FDA-2019-P-0915 · 4 docket documents Sunshine Lake Pharma Co., Ltd. filed a suitability petition regarding Vimpat, requesting FDA review and confirmation that the company's proposed ANDA or generic drug product would be suitable for approval based on the reference listed drug's established safety and efficacy profile. | Suitability | 2019-02-26 | Open | Sunshine Lake Pharma Co., Ltd. |
UCB, Inc. - Citizen Petition FDA-2013-P-1397 · 3 docket documents UCB, Inc., submitted this citizen petition under section 505(q) of the Federal Food, Drug, and Cosmetic Act requesting that FDA determine the new chemical entity exclusivity period for lacosamide, marketed as Vimpat, should begin on June 9, 2009 (when the drug could be legally marketed following con | 505(q) Stay Request | 2013-11-27 | Denied | — |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| D-188 | Apr 28, 2026 | Expired |