Futura All Set For US FDA De Novo Application For Eroxon OTC ED Treatment
Futura Medical is preparing to seek approval from the FDA to launch OTC in the US its MED3000 erectile dysfunction treatment, marketed in Europe under the Eroxon brand name. After completing all the necessary studies demonstrating that the gel-based, drug-free product works as a self-care treatment for ED, Futura says it is confident that the soon to be submitted de novo medical device application will be successful and pave the way for a Q1 2023 launch.
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Drug-free erectile dysfunction “stimgel” creator Futura wants to see if the technology underpinning Eroxon can be applied to female sexual dysfunction. Breaking into China is also high up on the agenda for the UK-based R&D company's CEO James Barder, he reveals in this exclusive interview.
According to Futura's UK distributor, the recent launch of its Eroxon drug-free erectile dysfunction gel has been an outstanding success. Ceuta's Jon Connolly described the strategy behind the launch at a recent investor event.
Approved through De Novo regulatory pathway used to classify novel medical devices for which there is no legally marketed predicate product, Eroxon, packaged in single-use tubes, gives Futura first entry to US market for OTC therapeutic products approved with ED indication.