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# FDA Denies Generic Imodium Petition
- URL: https://www.fdaweb.com/fda-denies-generic-imodium-petition/
- Published: 2024-04-17T12:00:00.000Z
- Updated: 2026-09-14T14:28:32.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156795

FDA has denied an 11/2/2023 petition submitted by Hyman, Phelps & McNamara seeking permission to submit an ANDA for loperamide HCl capsules 1 mg and 4 mg, citing a reference to Johnson & Johnson’s Imodium capsules 2 mg. The agency’s 4/17 denial [letter](https://downloads.regulations.gov/FDA-2023-P-4873-0007/attachment%5F1.pdf?ref=fdaweb.com) says that one of the requirements for a 505(j)(2)(C) petition is there is no NDA approved for the change sought in the petition. It says there already is an NDA approved for the 1 mg strength of loperamide HCl capsules, held by BionPharma.

The request for approval to submit a 4 mg dosage ANDA was likewise denied because the proposed change raises questions of safety that would require significant labeling changes to address the newly introduced safety problem posed by the proposed strength, which differs from the listed drug product, FDA says.