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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...

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Base Benefit-Risk Decisions On Data, Not Opinion And Passion, CDER’s Tidmarsh Says

 
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More from Agency Leadership

Lilly Wins EU Thumbs Up For Kisunla After EMA Reverses Rejection

 
• By Neena Brizmohun

The European Medicines Agency says that Eli Lilly's Alzheimer's disease drug should be approved for use in the EU, now that it has re-examined the negative opinion it previously adopted.

US FDA’s Biologics Center Departures Grew Before More Than 100 RIFs Exited

 
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The Center for Biologics Evaluation and Research saw departures far outnumber new hires in the second and third quarters of FY 2025, before more than 100 people left July 14 after the reduction-in-force was finalized.

US FDA Cancer Reviewers Heading For The Exits, Potentially Impacting Review Timelines

 
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US FDA's cancer drugs division is feeling the effect of drug reviewer departures, despite efforts to keep them at the agency.