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Emergent Expects Moving OTC Naloxone Directions On Package To Sway US FDA Advisory Panel

 
• By Malcolm Spicer

Based on results from its study for switch NDA, with primary endpoint of users’ success in administering naloxone nasal spray, Emergent changes which DFl panels include the directions. FDA will tell advisory committee the firm has no study data validating effectiveness of changes.

• Source: Shutterstock

Emergent BioSolutions, Inc. will ask a US Food and Drug Administration advisory panel to agree that rearranging the placement of directions within labeling it tested for OTC use of its naloxone nasal spray will eliminate user errors which concern agency officials.

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More from Rx-to-OTC Switch

Over The Counter: Evolving The UK Consumer Health Industry, With PAGB’s Michelle Riddalls

 
• By David Ridley

HBW Insight catches up with PAGB CEO Michelle Riddalls to chat about the association's new five year plan. Riddalls also reflects on the successes of the last five years, including relaunching the UK Reclassification Alliance, which has published a list of Rx-to-OTC switches the government would like to see applications for. Part one of two.

Arkansas Law For OTC Ivermectin Sales Doesn’t Answer Dose, Format And Access Questions

 
• By Malcolm Spicer

“I’m not sure exactly if they understood how broad this actually is and what that might potentially lead to or what the follow-up would be if somebody now decides to sell a 10-milligram version of ivermectin for human use,” says food and drug regulation attorney Frederick Stearns.

Eisai Switches Proton Pump Inhibitor Rabeprazole To OTC In Japan

 
• By David Ridley

Eisai aims to support people in Japan with severe heartburn and discomfort caused by gastric acid related conditions by switching from prescription to OTC status its Pariet-branded proton pump inhibitor.

AESGP: ‘No Evidence’ Of Antimicrobial Resistance With OTC Antifungals Or Antivirals

 
• By David Ridley

Two AESGP papers reviewing the evidence for AMR risk associated with a range of OTC antifungals and antivirals conclude there is litte to no risk associated with the responsible self-care use of such medicines.

More from Health

Pharma Still Nervous While Riding Trump’s Tariff Rollercoaster

 
• By Jessica Merrill

The rollout of Trump’s plan has been a policy whiplash, but despite a 90-day pause on tariffs, the US president still appears to be holding a grudge with industry over drug pricing.

KKR Expands Health & Beauty Portfolio With Deal For Sweden’s Karo

 
• By Tom Gallen

Consumer health player Karo is changing hands from EQT to KKR in a deal thought to value the Stockholm-based firm at over €2.5bn.

EU Parliament Agrees To Postpone Due Diligence And Sustainability Reporting Rules

 
• By David Ridley

Speaking at a recent AESGP webinar, sustainability expert Onur Durmus called the the European Commission’s “Omnibus” proposals - designed to simplify ESG reporting rules and recently supported by EU Parliament - a “positive development” for the European consumer health industry.