HBW Insight is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

FDA Has Model Drug Facts Labels For OTC Naloxone, Wants Switch Proposals

Executive Summary

Development of the model DFLs was a first for agency, reflecting alarm over public health crisis of overdoses from opioid abuse, which reached nearly 48,000 in 2017. The project was "part of our broader commitment to addressing the opioid crisis" and should help sponsors with potential naloxone OTC switch NDAs, says Commissioner Scott Gottlieb.

You may also be interested in...



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

Financial model is not adequate right now, FDA Commissioner Robert Califf says, so the agency may make regulatory changes to motivate sponsors.

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

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

Australian Pharmacists Support Providing Nonprescription Naloxone But Training Unavailable

Two studies revealed a lack of knowledge by pharmacists in Australia about providing naloxone despite being available without a prescription from pharmacists since 2016. Results could be an indication of potential problems if the opioid antagonist is made available nonprescription in US. 

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

RS148450

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel