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# FDA Lifts Hold on Cialis Rx-to-OTC Study
- URL: https://www.fdaweb.com/fda-lifts-hold-on-cialis-rx-to-otc-study/
- Published: 2025-01-22T12:00:00.000Z
- Updated: 2026-09-14T14:51:25.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5158530

FDA has lifted a 2022-placed clinical hold on a Sanofi actual use trial to support its planned Rx-to-OTC switch for Cialis (tadalafil), which it licensed from Eli Lilly. The agency said at the time that the hold is related to issues surrounding the trial’s protocol design, according to the company.

Lilly’s Cialis is currently approved as a prescription treatment for erectile dysfunction and the signs and symptoms of benign prostatic hyperplasia.