The Food and Drug Administration (FDA, Agency, or we) has determined that MYSOLINE (primidone) suspension, 250 milligrams (mg)/5 milliliters (mL), was withdrawn from sale for reasons of safety or effectiveness. The Agency will not accept or approve abbreviated new drug applications (ANDAs) for primidone suspension, 250 mg/5 mL.
| Document Number | 2025-24196 |
| FR Citation | 91 FR 148 |
| Type | Notice |
| Published | Jan 2, 2026 |
| Effective Date | - |
| RIN | - |
| Docket ID | Docket No. FDA-2022-P-3118 |
| Pages | 148–149 (2 pages) |
| Text Fetched | No |
| Part | Name | Agency |
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| No linked CFR parts | ||
| Type | Proposed | Final | Method | Conf |
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