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


Merck Cozaar Nephropathy Label Should Include Cardioprotection Uncertainty

Executive Summary

Merck's Cozaar labeling for type 2 diabetic nephropathy should convey questions about cardioprotective effect and caution about substitution for ACE inhibitors, FDA's Cardiovascular & Renal Drugs Advisory Committee suggested at its April 12 meeting

You may also be interested in...

Accelerated Approval Great For “Me-Too” Products, FDA Says

CDER’s Bob Temple explains how competitors could actually help speed up a drug approval but also hold a product to a higher standard.

FDA Debates The “Slowdown”: Temple Sees No Sign Of Excess Caution

An analysis of recent drug approvals that took longer than one year shows no indications of a more conservative attitude by FDA, Office of Medical Policy Director Robert Temple, MD, told the Food & Drug Law Institute conference April 17 in Washington, D.C

Merck Cozaar Approval Nod For Nephropathy Gets Boost From Avapro Data

An advisory committee recommendation for Merck's Cozaar in the treatment of nephropathy in type 2 diabetes patients reflects supportive evidence from Bristol-Myers Squibb/Sanofi's Avapro data.

Related Content




Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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