Pink Sheet is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

LABA Label Changes Could Reinvigorate Single-Ingredient Products

Executive Summary

FDA's new labeling and use guidelines for long-acting beta agonists may present some sales challenges, but also may create a new market for older drugs

You may also be interested in...



Foradil Completes LABAs’ Exit From Risk Evaluation and Mitigation Strategies

FDA says Novartis’ assessment of the long-acting beta agonist’s REMS, which consisted only of a communication plan, shows the “plan, and therefore the REMS, has met its goal.”

REMS For Opioids, LABAs May Be Driven By PBM "Feedback" Mechanism

Possible contract from FDA would involve assessing whether PBM distribution of safety information to physicians would change prescribing practices.

LABA Safety Studies, REMS Are Next Topics For Sponsors, FDA After Relabeling

Discussions about how best to study the safety of long-acting beta agonists are ready to resume now that FDA has issued a revised label for the drug class

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS052295

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