Sanofi's Opella: FDA Lifts Clinical Hold On OTC Cialis Trial

(RTTNews) - Sanofi's Consumer Healthcare division, Opella, announced that the U.S. Food and Drug Administration has lifted a clinical hold on its planned actual use trial (AUT). The trial is aimed at transitioning Cialis (tadalafil) from a prescription-only medication to an over-the-counter option. With this decision, the actual use trial can now proceed, marking Cialis as the first PDE-5 inhibitor to reach the significant milestone.

Cialis (tadalafil) in the US is currently only available with a prescription. Cialis is a tablet taken to treat erectile dysfunction (ED), the signs and symptoms of benign prostatic hyperplasia (BPH), and both ED and the signs and symptoms of BPH.

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