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

Advair, Serevent add "black box"

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

GlaxoSmithKline's asthma treatments Advair Diskus (fluticasone/salmeterol) and Serevent (salmeterol) labeling is revised to include "black box" warnings on an increased risk of asthma-related deaths in salmeterol-treated patients. Warnings for both products state that patients receiving salmeterol on top of a usual asthma regimen "showed a small but significant increase in asthma-related deaths" vs. placebo, an Aug. 14 FDA "Talk Paper" states. The effect was more pronounced in African American patients. The finding comes from GSK's Salmeterol Multicenter Asthma Research Trial (SMART); the firm alerted physicians in January that it had halted the study due to the findings and enrollment difficulties. "It is not known whether the findings seen with Serevent…would apply to Advair," Advair's labeling states. FDA is considering the possibility of a beta agonist class effect...

You may also be interested in...



Keeping Track: Cancer Approvals From Lumisight Imaging To Adjuvant Alecensa

The US FDA’s approval of Lumicell’s optical imaging agent Lumisight makes a dozen novel approvals in 2024 for the Center for Drug Evaluation and Research.

Partisan Politics Returns To US FDA Congressional Oversight

The US FDA has stood out as an agency that tends to draw broad bipartisan support amid a generally rancorous and divided Congress. A House hearing, however, may be a sign that those days are over.

GLP-1 Coverage Restrictions In Medicare Part D Surge As Demand For Obesity Drugs Grows

A major shift from unfettered coverage to prior authorizations was recorded by MMIT over the past year for the leading GLP-1/GIP agonist diabetes drugs. Public interest in using the drugs off label for weight loss drove the change.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS002348

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