Petros Includes Nitrate Patients In OTC ED Drug Self-Selection Studies
Firms also notes in its announcement that FDA typically requires actual use trials for switch NDAs in addition to label comprehension studies, which it has conducted, and self-selection studies.
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Poland becomes the first country in the world to allow erectile dysfunction treatment tadalafil to be bought without a prescription thanks to a successful Rx-to-OTC switch application from local player Adamed Pharma.
With ED ingredients frequently mentioned as OTC switch candidates in US, Hims & Hers Health is another latest direct-to-consumer marketer establishing network of retailers to offer potential OTC ED drug as it makes its consumer health and personal care products available in stores.
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.