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

Angiomax Approved For Use In Percutaneous Coronary Intervention

This article was originally published in The Pink Sheet Daily

Executive Summary

The indication includes “provisional” use with concomitant glycoprotein IIb/IIIa inhibitors. FDA had previously found the supplemental NDA, based on the REPLACE-2 study, “not approvable.” The Medicines Company appears not to have needed an additional study.

You may also be interested in...



Angiomax “Not Approvable” For Acute Coronary Syndromes

The Medicines Company says FDA letter is "vague"; concerns pertain to non-inferiority design for ACUITY trial.

Angiomax “Not Approvable” For Acute Coronary Syndromes

The Medicines Company says FDA letter is "vague"; concerns pertain to non-inferiority design for ACUITY trial.

Angiomax Gains Second Label Expansion For 2005

Supplement cleared Nov. 30 allows use of the anticoagulant bivalirudin in percutaneous coronary intervention patients at risk for heparin-induced thrombocytopenia or thrombosis syndrome.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS062376

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