Federal Register #NDA 010401

FDA Withdrawal of Approval for MYSOLINE (Primidone) Suspension, 250 mg/5 mL

This notice from the Food and Drug Administration (FDA), under the Department of Health and Human Services, announces the regulatory withdrawal of approval for MYSOLINE (primidone) suspension, 250 mg/5 mL. - Government Buyer: - Food and Drug Administration (FDA), Department of Health and Human Services - OEM/Vendor: - FHTA LLC (holder of NDA 010401) - Product Affected: - MYSOLINE (primidone) suspension, 250 mg/5 mL - NDA 010401 - Reason for Withdrawal: - Concerns about potential microbial contamination (Pseudomonas aeruginosa) - Requirement for reformulation to meet safety and effectiveness standards - Notable Requirements: - FHTA LLC agreed to withdrawal and waived hearing rights - No new formulation approved - Distribution of MYSOLINE (primidone) suspension, 250 mg/5 mL without FDA approval is prohibited - No procurement or award is being made; this is a regulatory withdrawal notice

Description

The Food and Drug Administration (FDA) is withdrawing approval of new drug application (NDA) 010401 for MYSOLINE (primidone) suspension, 250 mg/5 mL, held by FHTA LLC. The withdrawal is effective as of September 29, 2026. FHTA agreed to the withdrawal and waived its opportunity for a hearing. The withdrawal follows concerns about potential microbial contamination and the need for reformulation to meet safety and effectiveness standards.

View original listing