Federal Register: FDA Revokes Approval for FHTA LLC Mysoline Suspension Following Contamination Concerns
September 29, 2026
September 29, 2026
WASHINGTON, Sept. 29 (TNSFR) -- The U.S. Department of Health and Human Services Food and Drug Administration issued the following action in the Federal Register.
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FHTA LLC; Withdrawal of Approval of New Drug Application for MYSOLINE (Primidone) Suspension, 250 Milligrams/5 Milliliters
The Food and Drug Administration (FDA) is withdrawing approval of new drug application (NDA) 010401 for MYSOLINE suspension, 250 milligrams (mg)/5 milliliters (mL), held . . .
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FHTA LLC; Withdrawal of Approval of New Drug Application for MYSOLINE (Primidone) Suspension, 250 Milligrams/5 Milliliters
The Food and Drug Administration (FDA) is withdrawing approval of new drug application (NDA) 010401 for MYSOLINE suspension, 250 milligrams (mg)/5 milliliters (mL), held . . .