US OTC Switch For Cialis At Top Of To-Do List For Sanofi’s North American Consumer Health Chief
Andrew Loucks moves to Sanofi from helm of consumer health and technology firm Sensory Cloud as business navigates gaining US OTC heartburn market share for Zantac brand, which it relaunched with famotidine replacing ranitidine as the active ingredient.
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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.
UK R&D firm Futura has launched in its home market its drug-free erectile dysfunction gel under the Eroxon brand, marketed by France's Cooper Consumer Health.
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.