German Government Wants Sildenafil, Tadalafil OTC
Germany's Ministry of Health surprised all those present at a recent BAH meeting by announcing it would like to see erectile dysfunction drugs like sildenafil and tadalafil available OTC. Such a move, however, would put the government at odds with drug regulator BfArM's Expert Committee for Prescription, which recently rejected an application for the Rx-to-OTC switch of sildenafil.
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As Sanofi reports Consumer Healthcare second-quarter sales up by 9%, the company is hopeful it can progress its plan to switch erectile dysfunction drug Cialis in the US following a constructive meeting with the FDA.
Potential hurdles FDA put in front of Sanofi’s planned tadalafil switch could be sign for agency’s expectations for moving other Rx ingredients to OTC. Sanofi announced its planned actual use trial to support OTC tadalafil use was “placed on clinical hold due to matters surrounding the protocol design.”
After 118.2% cough/cold sales growth leads 17% overall consumer business growth, Sanofi points to still stronger days ahead while keeping the business under the same roof with its pharmaceutical and vaccine divisions.