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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

Access To Discounted Naloxone In California Expanded To All Consumers With Potential Need

 
• By Adam Zamecnik

After the product’s initial launch in May 2024, California’s government has now expanded the availability of its CalRx-branded generic OTC Narcan to all of its citizens.

Over The Counter: Brands, Brexit And New Self-Care Business Models, With PAGB’s Michelle Riddalls

 
• By David Ridley

HBW Insight catches up with UK OTC industry association CEO Michelle Riddalls to talk about digital self-care and the unrealized promise of Brexit - part 2.

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.

More from Health

US Q1 Consumer Health Earnings Preview: Concern Unavoidable For Impact From ‘T’ Word

 
• By Malcolm Spicer

Concern is unavoidable for most marketers of OTC drugs and dietary supplements in the US. As Canaccord Genuity analysts said in a 15 April research note, “uncertainty remains about how the tariff situation will play out.”

Over The Counter: Brands, Brexit And New Self-Care Business Models, With PAGB’s Michelle Riddalls

 
• By David Ridley

HBW Insight catches up with UK OTC industry association CEO Michelle Riddalls to talk about digital self-care and the unrealized promise of Brexit - part 2.

Euro Q1 Consumer Health Earnings Preview: Haleon, Reckitt, Bayer

 
• By Tom Gallen

Major Europe-based consumer health players Haleon, Reckitt and Bayer feature in this sales and earnings preview, which highlights what to look out for as these three firms report their Q1 2025 results over the coming weeks.