While Sanofi’s go-ahead for an actual use trial for OTC Cialis marks a first in the US, tadalafil became available nonprescription for the first time in Poland following a February decision by its drug and medical products regulator allowing OTC sales of Adamed Group’s Tadalafil MaxOn (10 mg).

The UK in 2017 became the first country to allow nonprescription sales of ED ingredient sildenafil, for Viatris Inc.'s Viagra, and Norway in 2019 approved the OTC switch of the drug under the brand Viagra Reseptfri by the firm formed in 2020 by the merger of Mylan Pharmaceuticals Inc. and Pfizer Inc.’s Upjohn off-patent and mature brands unit.

Perrigo Company PLC, Teva Pharmaceutical Industries Ltd. and Dr. Reddy’s Laboratories Ltd. since have launched nonprescription sildenafil sales in the UK. Germany, however, earlier in 2022 rejected a proposal to lift the country’s prescription requirement for sildenafil.

Sanofi in 2014 acquired exclusive rights for Cialis OTC approval in the US, Europe, Canada and Australia from innovator Eli Lilly & Co. and in 2016 indicated it was talking with the FDA about submitting a switch NDA for Cialis, which is available Rx in the US in 2.5-, 5-, 10- and 20-mg doses and can be used as needed or once daily. (Also see "Sanofi Licenses OTC Tamiflu From Roche To Attempt First US Flu Treatment Switch" - HBW Insight, 23 July, 2019.)

Sanofi Starting US Cialis OTC Actual Use Study Soon While Tamiflu Switch Progress Delayed

French Pharma Reports €1.33Bn Q1 Consumer Health Sales Helped By Price Increases

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