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Approvals For Stronger NSAIDs Label Warning About Risks During Late Pregnancy Begin In US

 
• By Malcolm Spicer

FDA since late October has sent approvals to firms which had submitted proposals for updates under the “If pregnant or breast-feeding” warning on their OTC NDAID DFls. First approval, dated 21 October, went to Bionpharma for its 200-mg ibuprofen tablets it provides for private label and store brand customers.

• Source: Alamy

A methyl salicylate transdermal patch and a topical with an ingredient made available nonprescription in the US in 2020 are among the first OTC nonsteroidal anti-inflammatory drugs re-labeled to more strongly warn against use during pregnancy or while nursing.

The Food and Drug Administration’s Center for Drug Evaluation and Research since late October has sent approvals to firms which had submitted proposals for updates under the “If pregnant or

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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

 
• By Eileen Francis and Lauren Nardella

The US Food and Drug Administration has released a roadmap to adopt new approach methodologies in lieu of animal testing for monoclonal antibody therapies and other drugs, which may include OTC drugs though the proposal does not specifically include cosmetics.

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.