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FDA Has Model Drug Facts Labels For OTC Naloxone, Wants Switch Proposals

 
• By Malcolm Spicer

Development of the model DFLs was a first for agency, reflecting alarm over public health crisis of overdoses from opioid abuse, which reached nearly 48,000 in 2017. The project was "part of our broader commitment to addressing the opioid crisis" and should help sponsors with potential naloxone OTC switch NDAs, says Commissioner Scott Gottlieb.

FDA entrance sign 2016

FDA underscored its interest in proposals for allowing OTC access to naloxone for treating opioid overdose by taking the unprecedented step of developing model Drug Facts labels that potential sponsors can use for their own label comprehension studies.

The agency announced the release of the model DFLs on Jan. 17 along with publication of its review of independent...

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More from Rx-to-OTC Switch

German Switch Committee Supports OTC Melatonin And Acyclovir, Rejects Rupatadine

 
• By David Ridley

Germany’s Expert Committee for Prescription supports the Rx-to-OTC switches of melatonin and buccal acyclovir but rejects rupatadine.

Navamedic To Market OTC Naloxone In Norway Following Switch

 
• By Tom Gallen

Navamedic adds Ventizolve to its portfolio shortly after Norway switched the opioid overdose reversal drug from Rx to OTC.

Viatris Switches Innovative Dual Action Nasal Spray In The UK

 
• By David Ridley

Now available without a prescription, Dymista Control is the first OTC combination treatment for consumers who are struggling to control their seasonal allergic rhinitis with a corticosteroid or antihistamine nasal spray, according to the firm.

Haleon Study: Self-Care Policies Could Save Finland €60m Per Year

 
• By David Ridley

Creating a working group to drive Rx-to-OTC switch is one of the ways in which Finland could expand self-care and save €60m per year for the country's health system, suggests a recently published report commissioned by Haleon.

More from Health

German Switch Committee Supports OTC Melatonin And Acyclovir, Rejects Rupatadine

 
• By David Ridley

Germany’s Expert Committee for Prescription supports the Rx-to-OTC switches of melatonin and buccal acyclovir but rejects rupatadine.

People On The Move: Appointments at BioGaia, Assosalute, Bayer

 
• By Tom Gallen

A round-up of the latest European people moves: BioGaia hires new subsidiary head from L'Oréal; Assosalute gets new director; Bayer renews contract of CEO.

Senate Bill Would Boost Oversight Of US FDA User Fee Program Following Trump Reorganization

 
• By Sarah Karlin-Smith

Senate appropriators also put FDA on notice regarding recent meetings and compliance with the Federal Advisory Committees Act, signal positive news on rare pediatric diseases, and offer hints of other agency areas they have close eyes on.