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.
The UK’s Futura Medical plc hopes its erectile dysfunction gel MED3000 will soon be approved as an OTC medical device in the US after completing what it believes to be all the necessary work required for approval.
Branded as Eroxon in Europe, MED3000 will be submitted for approval via the US Food and Drug Administration’s de novo...
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