TGA rejects sildenafil OTC application

Downscheduling could delay diagnosis of CVD, committee concludes

A bid to make an erectile dysfunction drug available without a prescription has been rejected by the TGA on the basis it could delay diagnosis of cardiovascular disease, which “cannot be diagnosed by a pharmacist”.


The TGA had been reviewing an application to make sildenafil (including Viagra, Pfizer) available over-the-counter in doses of 50mg or less, under the supervision of a pharmacist with extra training.

According to the application, the downscheduling of sildenafil would “destigmatise” erectile dysfunction and raise awareness