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# Novartis’ Miochol Not Withdrawn Over Safety/Efficacy: FDA
- URL: https://www.fdaweb.com/novartis-miochol-not-withdrawn-over-safety-efficacy-fda/
- Published: 2019-07-15T12:00:00.000Z
- Updated: 2026-09-15T01:37:52.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5144527

*Federal Register* notice: FDA has determined that Novartis’ NDA for Miochol (acetylcholine chloride intraocular solution), 20 mg/vial, was not withdrawn from sale due to safety or effectiveness issues. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are met. Miochol is indicated to obtain complete miosis of the iris in seconds after delivery of the lens in cataract surgery. To view the notice, click [here](https://s3.amazonaws.com/public-inspection.federalregister.gov/2019-15089.pdf?ref=fdaweb.com).