The company announced Monday that the US Food and Drug Administration granted marketing authorization for the over-the-counter sale of the gel, which it says is the first topical erectile dysfunction treatment available without the need for a prescription. The FDA confirmed Monday that Eroxon has been granted a “de novo” classification, a nod to the gel being a new type of product. The de novo decision was made Friday.
The timing of when Eroxon will be available on store shelves in the US also depends on that partner, but some financial analysts predict that the product could launch in 2025. A leaflet for the product notes that the gel comes in a single-dose tube and should be applied to the head of the penis for 15 seconds before sex. Marketing materials for the product claim that it can help users get an erection within 10 minutes of application.