FDA Pauses Cialis Prescription-to-OTC Trial

The US Food and Drug Administration (FDA) has put a wrench in Sanofi’s efforts to transition its erection dysfunction medication from prescription-to-OTC. The agency paused Sanofi’s “actual use trial” before it recruited any patients due to concerns about protocol design.

According to, “Sanofi snagged exclusive rights to licensing the drug on a nonprescription basis in the U.S., Europe, Canada and Australia from Eli Lilly back in 2014. The erectile dysfunction (ED) drug was approved by the FDA in 2003 and gained approval in more than 120 counties for varied indications, including benign prostastic hyperplasia.“

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(Source: Fierce Pharma, Jun 1^st, 2022)