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Erectile Dysfunction Gel Gets FDA OTC Marketing Authorization

June 14, 2023

Futura Medical has been granted the first FDA OTC marketing authorization for its MED3000, a topical gel for the treatment of erectile dysfunction (ED).

MED3000, to be marketed as Eroxon, uses the company’s transdermal DermaSys technology, which has been clinically proven as a treatment for ED with a 10-minute onset of action, the company said.

One in five men suffer from ED, the company said, totaling about 22 million men in the U.S.

The gel is UKCA marked for distribution in the UK and has the CE mark in the EU.

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