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US Oral Contraceptive OTC Switch Sponsor Says ‘Challenging Target’ Met For Adolescents In Study

 
• By Malcolm Spicer

HRA executives and other representatives for firm and FDA officials will make presentations about HRA’s sNDA to agency’s Nonprescription Drug and Obstetrics, Reproductive and Urologic Drugs advisory committees during a joint meeting on 9-10 May.

• Source: Shutterstock

HRA Pharma spares no detail on the benefits of allowing adolescent access in the information it provided to an advisory panel recommending whether the Food and Drug Administration should approve its proposal for the first Rx-to-OTC switch of a daily oral contraceptive in the US.

The Perrigo Company PLC subsidiary also counters FDA concerns about the numbers of adolescent and of low healthy literacy participants in the actual use study it conducted to support its supplemental new drug application for

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New Zealand Could Become First Country To Offer Gout Drug Allopurinol OTC

 
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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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Melatonin And Buccal Acyclovir On German Switch Committee Agenda

 
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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.