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Label Comprehension Results Point Petros Toward OTC Self-Selection Study For Stendra ED Drug

 
• By Malcolm Spicer

Petros considers switch NDA for Stendra (avanafil), approved for Rx sales in US since 2012 on an NDA by Metuchen. Early indicators showed positive outcomes in a 453-subject label comprehension study for the oral PDE5 inhibitor.

• Source: Alamy

Petros Pharmaceuticals Inc. marks the first anniversary of its launch through the merger of Neurotrope Inc. and Metuchen Pharmaceuticals LLC with a report of strong OTC label comprehension results for an erectile dysfunction drug.

Petros is considering submitting a new drug application to the US Food and Drug Administration for an OTC switch of...

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• By David Ridley

Germany’s Expert Committee for Prescription supports the Rx-to-OTC switches of melatonin and buccal acyclovir but rejects rupatadine.