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‘Nothing Unexpected’ In Third Failed Application For OTC Sildenafil In Germany

 
• By David Ridley

“Overall, no unexpected/new data or findings” were presented to Germany's Expert Committee for Prescription in the most recent Rx-to-OTC switch application for sildenafil (25mg and 50mg), according to medicines regulator BfArM, resulting in a third rejection in three years.

Rejected
Viatris' application to switch sildenafil to OTC status in Germany rejected for third time

Germany’s Expert Committee for Prescription remained unmoved by the evidence and arguments presented by an unnamed applicant in favor of a third Rx-to-OTC switch application for sildenafil.

In fact, German medicines agency BfArM in its presentation to the committee said it saw nothing new in the application,...

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