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

Merck's Bridion Approval Carries Several Post-Market Requirements

This article was originally published in The Pink Sheet Daily

Executive Summary

Merck must conduct studies to determine likely non-responders, assess occurrence of hypersensitivity or anaphylaxis, evaluate risk of cardiac arrhythmias, and study sugammadex's effects in morbidly obese patients.

You may also be interested in...



Merck's Sugammadex Sails Through FDA Panel But Faces Post-Approval Studies

Advisory committee suggests post-marketing epidemiological studies in higher risk patients to further assess risks of hypersensitivity, anaphylaxis and cardiac rhythm disorders with the neuromuscular blockade reversal agent.

Standardization Of Patient-Focused Core Clinical Outcomes Could Enable Labeling Comparisons

US FDA’s Theresa Mullin envisions having a national catalog of standard core clinical outcomes assessment measures that could apply to every disease area.

Delisting Of Jazz’s Xyrem Patent In Orange Book Could Spur More Infringement Counterclaims

Jazz’s REMS patent on distribution of Xyrem does not belong in the Orange Book because it is directed to systems rather than a method of using the drug, court rules, agreeing with FTC’s analysis.

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

PS078091

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