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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...

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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.

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.

EU Pharma Reform: Council Proposes Rx Exemption For Topical Antimicrobials

 
• By David Ridley

The EU Council has introduced a key amendment to Article 51 (para 1, point e) of the new pharma directive: “A medicinal product shall be subject to medical prescription where it is an antimicrobial, unless intended for topical use.”

AESGP Annual Meeting: Commission Must ‘Think Carefully’ Before Reverse-Switching Antimicrobials

 
• By David Ridley

If the European Commission is serious about improving the competitiveness of the European Union, it should ditch the idea of making commonly used OTC antimicrobials like thrush treatments and cold sore creams prescription-only, warns Greek Medicines Agency president Evangelos Manolopoulos

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P&G’s Crest Gum Detoxify Ad Claims Rinsed Clean In NAD Review On GuruNanda Challenge

 
• By Malcolm Spicer

P&G provided sufficient support for all challenged claims, including the “Gum Detoxify” brand used on the product label and in advertising on the website and in magazine detail pages.

Xlear Lawsuit Argues To Shelve FTC Policy For Health Claim Substantiation Under Loper Bright

 
• By Malcolm Spicer

Complaint filed Utah federal court says “Supreme Court explicitly rejected Chevron deference to agency interpretations” in the Loper decision, compelling rejection of “an agency’s statutory interpretation unless the court, ‘after applying all relevant interpretive tools, concludes’ the interpretatio

People On The Move: Appointments At Pharma Deutschland, AMA, FSA

 
• By Tom Gallen

A round-up of the latest people moves: Pharma Deutschland names head of new OTC Market division; the African Medicines Agency appoints director general; the UK's Food Standards Agency adds members to novel foods committee.