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

FDA Supports Pradaxa Approval, But Without Superiority Claim

This article was originally published in The Pink Sheet Daily

Executive Summary

Agency charges the Sept. 20 Cardiovascular and Renal Drugs Advisory Committee with evaluating the relative benefit of preventing strokes with the increased risk of bleeding posed by Boehringer Ingelheim's dabigatran.

You may also be interested in...



FDA Plays It Safe With Boehringer Ingelheim's Pradaxa By Approving A Single Dosing Option

Regulators accept bleeding risk for superiority over warfarin, staying away from a temptingly safer but less effective dabigatran dose.

FDA Plays It Safe With Boehringer Ingelheim's Pradaxa By Approving A Single Dosing Option

Regulators accept bleeding risk for superiority over warfarin, staying away from a temptingly safer but less effective dabigatran dose.

FDA's Pradaxa Quandary: Clearing Both Doses Could Mask Dabigatran's Superiority

The pivotal issue remaining for FDA's review of Boehringer Ingelheim's Pradaxa (dabigatran) is whether it will clear both the 110 mg and 150 mg doses and how it can craft labeling to guide appropriate use toward the higher dose, which seems likely to gain a superiority claim over warfarin.

Related Content

Topics

Latest News
See All
UsernamePublicRestriction

Register

PS071183

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