Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

FDA Deems Angiomax sNDA "Not Approvable"

This article was originally published in The Pink Sheet Daily

Executive Summary

Bivalirudin supplemental application for patients undergoing percutaneous coronary intervention contained deficiencies in both the study methods and the analysis, FDA finds. Drug sponsor The Medicines Company plans to request a meeting with the agency.

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

UsernamePublicRestriction

Register

LL009864

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