TAVIST

FDA-2025-P-6088

Hyman, Phelps & McNamara, P.C. filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Clemastine Fumarate Tablets in 1.34 mg and 0.67 mg strengths suitable for submission as an ANDA for prescription use, with the referenc

FDA-2024-P-0761

Pharmobedient Consulting, LLC filed this citizen petition requesting that the FDA determine whether TAVIST (Clemastine Fumarate) Tablets, 2.68 mg, approved under NDA 017661 and held by Novartis, was withdrawn from commercial distribution for safety or efficacy reasons or only for commercial consider

FDA-2023-P-4292

Pharmobedient Consulting LLC filed a suitability petition regarding clemastine fumarate, requesting FDA assessment of the drug's suitability for development as a pharmaceutical product.

FDA-2023-P-4330

Pharmobedient Consulting, LLC filed a citizen petition regarding clemastine fumarate, the active ingredient in TAVIST, requesting a determination of suitability for abbreviated new drug application (ANDA) filing under the Orange Book regulatory framework.

FDA-2023-P-4330

Pharmobedient Consulting, LLC filed this suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act and 21 C.F.R. § 314.93 requesting that the FDA determine that Clemastine Fumarate Orally Disintegrating Tablets 2.68 mg is suitable for submission in an ANDA, based on

FDA-2023-P-4292

Pharmobedient Consulting LLC filed a suitability petition regarding clemastine fumarate, requesting a determination of the drug's suitability for inclusion in an abbreviated new drug application or generic drug product development program.