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

Endo's Belbuca Is First Buccal Film In Extended-Release Opioid Class

This article was originally published in The Pink Sheet Daily

Executive Summary

While Belbuca represents a new formulation, it does not contain the abuse-deterrent properties that FDA has been encouraging.

You may also be interested in...



Opioid Post-marketing Studies: Can Sponsors Work Well Together Again?

FDA wants to get a handle on how long-term use of long-acting pain killers relates to abuse and misuse; the agency also is requiring labeling changes that remove “moderate” pain from the products’ indication.

Opioid Prescriber Knowledge Assessment Due Year After Patient Assessment

REMS assessment schedule for the long-acting/extended release opioid products reflects the large number of drugs, prescribers and patients involved in the risk management program and the time needed to put all its components in place.

COVID Vaccine Boosters: US Exploring Ways To Get Immunocompromised People An Extra Dose

Dosing is capped under emergency use authorizations, but studies show reduced antibody response following primary vaccination series in individuals with compromised immune systems; although BLA approval could allow for off-label prescribing, government officials are exploring other regulatory options for earlier access, including through a study.

Topics

Related Companies

Related Deals

UsernamePublicRestriction

Register

PS077920

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