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# Ritalin NDA Not Withdrawn Due to Safety/Effectiveness: FDA
- URL: https://www.fdaweb.com/ritalin-nda-not-withdrawn-due-to-safety-effectiveness-fda/
- Published: 2017-09-06T12:00:00.000Z
- Updated: 2026-09-14T22:47:04.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5139562

*Federal Register* notice: FDA has determined that a Novartis NDA for Ritalin LA (methylphenidate hydrochloride) extended-release capsules, 60 mg, was not withdrawn from sale for reasons of safety or effectiveness. The determination will allow the agency to approve ANDAs referencing the NDA if all other legal and regulatory requirements are met. The product was initially approved in 2014\. for treating attention deficit hyperactivity disorder. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2017-09-06/pdf/2017-18817.pdf?ref=fdaweb.com).