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OTC Naloxone May Get Another Push From US FDA As Agency Prepares Novel Switch Proposed Rule

 
• By Derrick Gingery

Financial model isn't adequate currently, FDA Commissioner Robert Califf says, and agency may make regulatory changes to motivate sponsors.

Narcan device
• Source: Shutterstock

Naloxone manufacturers could receive another regulatory nudge from the US Food and Drug Administration to produce an OTC nasal spray of the opioid overdose medication.

Commissioner Robert Califf said the agency is having “serious discussions right now about what we can do to exert some changes compared to the

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More from Rx-to-OTC Switch

New Zealand Could Become First Country To Offer Gout Drug Allopurinol OTC

 
• By David Ridley

At the second attempt, New Zealand’s Medicines Classification Committee supported the Rx-to-OTC switch of allopurinol (100mg and 300mg) for people suffering from gout by specifically trained pharmacists.

Over The Counter: Everything You Wanted To Know About Real World Evidence, With IQVIA’s Volker Spitzer

 
• By David Ridley

HBW Insight finds out all about real world evidence and its potential for the OTC industry by chatting with IQVIA Consumer Health's vice president of global research and development and real-world evidence services, Volker Spitzer.

Trump Order To Improve Making More Drugs Available OTC Puts Wind Behind Petros’ ACNU Sails

 
• By Malcolm Spicer

Petros will incorporate into its platform an analytics firm’s automated document capture and authentication system leveraging its global ID library to verify identity and eligibility of consumers accessing the self-selection process for an ACNU switch.

Melatonin And Buccal Acyclovir On German Switch Committee Agenda

 
• By David Ridley

An application for melatonin as an OTC medicine is on the agenda for the next German switch committee meeting, despite the hormone being widely available in food supplements. Acyclovir as a buccal tablet and second-generation antihistamine rupatadine are also up for discussion.

More from Health

Venture Life Focuses On CHC As It Offloads CDMO

 
• By Tom Gallen

UK-based Venture Life is divesting its CDMO business and some non-core products to focus its attention on growing its consumer health operation.

New Zealand Could Become First Country To Offer Gout Drug Allopurinol OTC

 
• By David Ridley

At the second attempt, New Zealand’s Medicines Classification Committee supported the Rx-to-OTC switch of allopurinol (100mg and 300mg) for people suffering from gout by specifically trained pharmacists.

Mitigating Tariff Impacts, Kenvue Adjusts Outlook

 
• By Malcolm Spicer

“The situation has evolved considerably” since Kenvue gave its initial full-year outlook in February, “and remains quite fluid,” says president and CEO Thibaut Mongon as firm reports Q1 net sales decreasing 3.9% to $3.7bn