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

NitroMed BiDil Heart Failure Indication For African Americans To Be Reviewed By Cmte.

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA's Cardiovascular & Renal Drugs Advisory Committee will meet June 16 to consider the resubmitted BiDil NDA. Drug could be first approval specifically for African Americans. Committee will also meet June 15 to discuss antihypertensive class labeling.

You may also be interested in...



NitroMed BiDil Recommended For Heart Failure In Self-Identified African-Americans

Indication to treat heart failure in the general population is discussed, but rejected, by FDA’s Cardiovascular & Renal Drugs Advisory Committee. Despite mortality benefit seen in A-HeFT, some committee members call strength of evidence a “close call.”

NitroMed BiDil Recommended For Heart Failure In Self-Identified African-Americans

Indication to treat heart failure in the general population is discussed, but rejected, by FDA’s Cardiovascular & Renal Drugs Advisory Committee. Despite mortality benefit seen in A-HeFT, some committee members call strength of evidence a “close call.”

FDA Proposes Antihypertensive Class Indication For Reducing CV Events

Adding an indication for reducing cardiovascular adverse event risk is one option FDA will have its Cardiovascular & Renal Drugs Advisory Committee consider for antihypertensive class labeling June 15. Other class labeling options offered in FDA briefing document would amend the clinical trials section.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS062117

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