1. HBW Insight
  2. >>Health
  3. >>Rx-to-OTC Switch

Naloxone Switch NDA Submitted As US FDA Signals Nonprescription Access Looks Safe, Effective

 
• By Malcolm Spicer

Harm Reduction Therapeutics submits NDA for OTC approval of a 3-mg naloxone nasal spray branded RiVive. CEO Michael Hufford says the NDA touches all the bases FDA detailed in notice it published on what’s needed in naloxone OTC switch proposals.

• Source: Shutterstock

Some questions the US Food and Drug Administration announced on 15 November about safe and effective use of naloxone as a nonprescription product could be answered in a new drug application submitted three weeks earlier.

Harm Reduction Therapeutics Inc. on 28 October submitted to the FDA its NDA for OTC approval of a 3-mg intranasal...

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 Rx-to-OTC Switch

More from Health

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.

Moberg Nail Fungus Line Takes Lead In Norway As Firm Plots EU Expansion

 
• By Tom Gallen

Terclara - Moberg’s proprietary topical formulation of terbinafine for fungal nail - has established itself as the market leader in Norway just months after its OTC launch. The firm is now plotting its expansion to additional EU markets.

PAGB: UK Gov Must Invest In Self-Care To Realize ‘Untapped Potential’

 
• By David Ridley

Reacting to chancellor Rachel Reeves' 2025 public spending review, PAGB welcomed increased funding for healthcare and life sciences while stressing the need to promote self-care practices.