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First OTC Gel for ED Approved by FDA

The FDA granted the gel a "de novo" classification, recognizing it as a new type of product.

Futura Medical
Futura Medical

In the US, approximately 30 million men experience erectile dysfunction, which can be caused by various factors such as diseases, medications, psychological factors, or certain behaviors. According to a recent CNN article, Futura Medical has announced that its topical gel for erectile dysfunction, called Eroxon, has received authorization from the FDA  for OTC marketing. This makes Eroxon the first topical ED treatment available without a prescription. The treatment is already available in Belgium and the UK, and it’s estimated that it could be launched in the US as early as 2025.

Eroxon is applied to the head of the penis for 15 seconds before sexual activity, and the gel claims to help users achieve an erection within 10 minutes of application. According to the company's marketing materials, the erection lasts long enough for successful sexual intercourse in about 65% of individuals and subsides naturally. 

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