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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Positive results from a confirmatory Phase III clinical study puts Futura Medical on track to file a dossier for drug-free erectile dysfunction gel MED3000 with the US Food and Drug Administration by the end of September 2022. This is in line with the company's timeline of approval as an OTC de novo medical device in Q1 2023.
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