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Delay For Sanofi’s OTC Cialis Study In US Could Be Sign of Hurdles Holding Back Other Switches

 
• By Malcolm Spicer

Potential hurdles FDA put in front of Sanofi’s planned tadalafil switch could be sign for agency’s expectations for moving other Rx ingredients to OTC. Sanofi announced its planned actual use trial to support OTC tadalafil use was “placed on clinical hold due to matters surrounding the protocol design.”

• Source: Shutterstock

The latest example of the high bar for approval in the US to make available OTC drug ingredients indicated for chronic conditions is Sanofi’s initiative to make erection dysfunction drug Cialis available nonprescription the latest example.

Potential hurdles the Food and Drug Administration put in front of Sanofi’s planned switch of tadalafil to be the first ED drug available nonprescription in the US, an OTC switch and marketing consultant says, could be a

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At the second attempt, New Zealand’s Medicines Classification Committee supported the Rx-to-OTC switch of allopurinol (100mg and 300mg) for people suffering from gout by specifically trained pharmacists.

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More from Policy & Regulation

US Tariffs Pose ‘Existential Threat’ To EU Medical Devices Industry

 
• By David Ridley

AESGP, MedTech Europe and other associations representing medtech companies including manufacturers of self-care devices call for such products to be included in European Commission proposals for “zero-for-zero” trade in industrial goods between Europe and the US.

Stakeholders Hope US FDA’s Proposed Animal Test Phase-Out For Drugs Will Extend To OTCs, Cosmetics

 
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Melatonin And Buccal Acyclovir On German Switch Committee Agenda

 
• By David Ridley

An application for melatonin as an OTC medicine is on the agenda for the next German switch committee meeting, despite the hormone being widely available in food supplements. Acyclovir as a buccal tablet and second-generation antihistamine rupatadine are also up for discussion.