Naloxone OTC Switch Application On Horizon Thanks To $3.4M Funding From Purdue

 
• By Eileen Francis

Harm Reduction Therapeutics, which has sought funding for a US Rx-to-OTC new drug application, receives grant from Purdue Pharma that enables filing and launching the product in a targeted 100,000 retail locations within two years.

Harm Reduction Therapeutics Inc. estimates the first Rx-to-OTC switch for naloxone could hit the US market within 18 to 24 months, thanks to a $3.42m grant provided by opioid drug maker Purdue Pharma LP.

The low-cost nasal spray, an opioid antagonist indicated for complete or partial reversal of opioid overdose – including respiratory depression...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on HBW Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Regulation

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

Animal Studies Would Not Provide ‘Meaningful Insights’ Into UV Filter Safety - Study

 
• By Lauren Nardella

A new study on the safety of sunscreen filters relies on an alternative assessment methodology and concludes that six sunscreen UV filters are unlikely to be carcinogenic.

EU’s Small, Medium Beauty Industry Pushing For Clarity In Revised CPR

French SME association COSMED will push the European Commission for a “clear checklist” and criteria on how substances in the Cosmetic Products Regulation are assessed by Member States, as well as more clarity on the exemption process and timelines.

US FDA Expert Panel Paints Bleak Picture For Future Of Talc In Cosmetics

 
• By Eileen Francis

The US FDA’s 20 May expert panel on talc discussed science behind the potential carcinogenicity of the cosmetic, food and drug ingredient, the importance of ‘good science’ in evaluating the substance and the need to find alternatives in each industry.

More from Policy & Regulation

FDA’s FY 2026 Budget Request Lacks New Policy Proposals

 
• By Sue Sutter

The White House requested $6.8bn for the FDA, down 3.9% from the current funding level, but does not propose any legislative changes. In previous years, the agency used the budget process to seek statutory fixes specific to generic drugs and shortages.

House Appropriators’ $3.2Bn For FDA In FY 2026 Includes More Non-User Fee Funds Than Requested

 
• By Sue Sutter and Derrick Gingery

A US House bill would give the FDA $33.1m more in budget authority than requested by the Trump Administration for fiscal year 2026. The measure was sent to the full House Appropriations committee on a party-line vote.

IBA Interactive Policy Map Is Call To Action As Cosmetics Industry Braces For Myriad Of State Bills

 
• By Eileen Francis

The Independent Beauty Association has launched an interactive Policy Map tracking state and federal bills and filtering by state or topic, pinpointing bills of great priority.