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# Kemstro Not Withdrawn Due to Safety/Efficacy
- URL: https://www.fdaweb.com/kemstro-not-withdrawn-due-to-safety-efficacy/
- Published: 2024-04-11T12:00:00.000Z
- Updated: 2026-09-14T14:28:08.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5156761

*Federal Register* notice: FDA has determined that UCB’s Kemstro (baclofen) orally disintegrating tablets, 10 mg and 20 mg, were not withdrawn from sale for reasons of safety or effectiveness. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are met. Kemstro is indicated for alleviating the signs and symptoms of spasticity resulting from multiple sclerosis, particularly for the relief of flexor spasms and concomitant pain, clonus, and muscular rigidity. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-04-11/pdf/2024-07722.pdf?ref=fdaweb.com).