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ED Indication Reaches US OTC Market With FDA Approval Of UK Firm Futura’s Eroxon Gel

 
• By Malcolm Spicer

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.

• Source: Shutterstock

The US erectile dysfunction therapeutic product market stretches into the OTC space with regulatory approval of UK firm Futura Medical plc’s Eroxon gel containing water, ethanol, propylene glycol, glycerin and carbomer potassium hydroxide.

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