Pink Sheet 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

Dsuvia Approval May Be Followed By New Opioid Review Paradigm At FDA

Executive Summary

US FDA Commissioner Gottlieb defended the decision to clear the controversial opioid in the agency’s press release on the approval, and announced a possible shift in how future opioid applications are reviewed.  

You may also be interested in...



Nektar's Novel Opioid For Lower Back Pain Heads To US FDA Panel For Wide-Ranging Discussion

Nektar's novel opioid oxycodegol will be the first opioid analgesic taken up by an advisory committee in more than a year after the agency spent 2019 reevaluating its regulatory paradigm.

Comparative Confusion: What Does FDA Intend For Opioid Comparative Efficacy Data?

Legally, FDA can't require comparative effectiveness data for approval, but draft guidance notes that the agency really wants it; for sponsors, that leaves more questions than answers, mainly: What will FDA do with an opioid application that doesn't contain such data.

Dsuvia: A Dull US FDA Review Preceded The Controversial Approval

US FDA's review of AcelRx's opioid Dsuvia did not presage the external fireworks that came following the approval.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS124193

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