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# Pennsaid Not Withdrawn Due to Safety/Efficacy
- URL: https://www.fdaweb.com/pennsaid-not-withdrawn-due-to-safety-efficacy/
- Published: 2024-08-20T12:00:00.000Z
- Updated: 2026-09-14T14:39:03.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5157606

*Federal Register* notice: FDA has determined that Horizon Therapeutics’ Pennsaid (diclofenac sodium) topical solution 2% was not withdrawn due to safety or effectiveness issues. The determination means that FDA will continue to approve ANDAs that reference the product as long as they meet relevant legal and regulatory requirements. The nonsteroidal anti-inflammatory drug is indicated for treating osteoarthritis pain in the knees. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2024-08-20/pdf/2024-18615.pdf?ref=fdaweb.com).