Skip to content
Product safetyFDAUnited StatesImports

FHTA LLC; Withdrawal of Approval of New Drug Application for MYSOLINE (Primidone) Suspension, 250 Milligrams/5 Milliliters

29 September 2026

In plain English

FDA is withdrawing approval of NDA 010401 for MYSOLINE (primidone) suspension, 250 mg/5 mL, held by FHTA LLC, with FHTA's agreement.

Read the official notice
Topic
Product safety
Regulator
FDA
Published
29 September 2026
For
Imports
Where it applies
United States
Source
FDA (Food and Drug Administration)

From the notice

The Food and Drug Administration (FDA or Agency) is withdrawing approval of new drug application (NDA) 010401 for MYSOLINE (primidone) suspension, 250 milligrams (mg)/5 milliliters (mL), held by FHTA LLC (FHTA). FHTA agreed to withdrawal of approval of this application and has waived its opportunity for a hearing.

Olive tells you which of these hit your products.

Olive reads every change like these against your own products, codes and trade lanes, whether you import, export or both, and drafts the update to your compliance program for your approval. Nothing changes without you.

Get startedLive demo

Olivra lists official notices for information only. It is not legal advice, and Olive is not a lawyer or a licensed customs broker. The official text at the source is what counts.

More from FDA

See everything Olive monitors