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 |
|---|---|---|---|---|
Suitability Citizen Petition from RegCon Solutions LLC FDA-2022-P-0747 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 | Open | RegCon Solutions LLC |
Attachment B Package Insert of Lacosamide Granules for Oral Solution re: Suit... FDA-2019-P-0915 Sunshine Lake Pharma Co., Ltd. filed a suitability petition regarding lacosamide granules for oral solution, requesting FDA evaluation of the proposed product formulation and manufacturing process to establish suitability for an abbreviated new drug application (ANDA) or comparable regulatory pathwa | Suitability | 2019-02-26 | Open | Sunshine Lake Pharma Co. |
Attachment A Package Insert of Reference List Drug (Vimpat ®) re Suitability ... FDA-2019-P-0915 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. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Code | Date | Status |
|---|---|---|
| D-188 | Apr 28, 2026 | Expired |