Why Did Germany Reject Sildenafil OTC Switch?
Sildenafil was rejected at Germany’s independent switch committee’s most recent meeting. HBW Insight examines some of the arguments for and against the switch put forward by the regulator, members of the committee and the applicant, as recorded in the recently published minutes.
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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.
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.”
Teva UK's first Rx-to-OTC switch is a UK Viagra Connect sildenafil competitor under the Liberize brand. Priced around 25% lower than the market leader, Teva's new brand must also compete with Perrigo's white label and Dr Reddy's Almus branded alternatives within the country's growing erectile dysfunction category.