TAVIST

FDA-2025-P-6024

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 Oral Syrup in three new strengths of 0.25 mg base/5 mL, 0.75 mg base/5 mL, and 1 mg base/5 mL suitable for submissi

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-4292

Pharmobedient Consulting, LLC filed this suitability petition under section 505(j)(2)(C) of the FDC Act requesting that the FDA declare Clemastine Powder for Solution in 1 mg and 2 mg Base per sachet suitable for submission in an ANDA, with the reference standard being the discontinued TAVIST oral s

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.