VIMPAT

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

FDA-2024-P-3293 · 11 docket documents

Newcastle Bioscience LLC filed this petition under Section 505(j)(2)(C) requesting that the FDA declare Lacosamide Orally Disintegrating Tablets in strengths of 25 mg, 37.5 mg, 75 mg, 112.5 mg, and 175 mg suitable for submission as an ANDA, using Vimpat (lacosamide) Tablets 200 mg as the reference-l

FDA-2023-P-4291 · 7 docket documents

Newcastle Bioscience LLC filed this citizen petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Lacosamide Orally Disintegrating Tablets in strengths of 50 mg, 100 mg, 150 mg, and 200 mg suitable for submission as an abbreviated new drug ap

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.

FDA-2017-P-4233 · 7 docket documents

Lachman Consultant Services, Inc. filed this petition on behalf of a client pursuant to Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting that the FDA declare Lacosamide Orally Disintegrating Tablets in strengths of 50 mg, 100 mg, 150 mg, and 200 mg suitable for submission

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