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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Futura Launches Eroxon Erectile Dysfunction Gel In Europe, US Launch Delayed Until Q2 2023
European consumers can now buy Futura Medical's Eroxon erectile dysfunction gel without a prescription online, and in person via Belgian pharmacies. Further country launches, supported by advertising and promotional campaigns, remain on track during the coming months, Futura says. However, the US launch, expected for Q1 this year, has been delayed while the firm answers questions posed by the FDA.
UK Cialis Rx-To-OTC Switch World-First For Sanofi, H2 2023 Launch Planned
The UK is the first country to allow OTC access to Sanofi's tadalafil-based erectile dysfunction drug Cialis following a successful switch. Approved as a pharmacy medicine, Sanofi will launch Cialis Together in the second half of the year. Cialis will compete against Viatris' sildenafil-based Viagra Connect in the men's sexual health and wellness category, which has seen a proliferation of products in recent months.
Cooper Preparing European Launch Of Eroxon OTC Erectile Dysfunction Gel
France's Cooper Consumer Health is aiming to get Futura's drug-free OTC Eroxon erectile dysfunction gel on European shelves in the next few months.