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OTC Switch For Naloxone Finding Interest Among Sponsors

 
• By Derrick Gingery

With FDA 'si label comprehension study near completion, sponsors seem more positive about OTC versions of naloxone products. FDA has made clear it is interested in switching the product from Rx-only but had trouble generating sponsor desire to develop it.

Puzzle

FDA is recruiting sponsors of potential OTC naloxone applications and reports that interest is high, although concerns over pricing and the absence of physician-patient communication about using the product could be impediments to a switch.

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More from Rx-to-OTC Switch

Preamble ‘Poison Pill’ Could Haunt ACNU Switch Rule – House Energy And Commerce Members

 
• By Malcolm Spicer

Reps. Latta, Crenshaw and Miller-Meeks contend language in ACNU final rule preamble would allow a sponsor of an approved application to litigate to halt Rx availability of same formulation and “risk eliminating the very rule on which its product approval was based.”

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.

More from Health

People On The Move: Appointments At Maxwellia, Nestlé, Alland & Robert

 
• By Tom Gallen

A round-up of the latest European health & wellness market moves: Maxwellia names chief operating officer; Nestle appoints marketing & sales head; Alland & Robert gets deputy general manager.

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.