Pravachol OTC Label Studies, Redefined Population Urged By Cmte.
This article was originally published in The Tan Sheet
Executive Summary
Bristol-Myers Squibb's Pravachol (pravastatin) 10 mg is an attractive candidate for OTC status, but the company should first conduct additional label comprehension studies and better define the target population for the cholesterol agent, FDA advisory committee members suggested July 14.
You may also be interested in...
CDER’s Galson Says Statin Switches May Be Ready For A Second Look
The time may be right for FDA to revisit statins as a possible Rx-to-OTC switch category of drugs, according to Acting CDER Director Steve Galson, MD
CDER’s Galson Says Statin Switches May Be Ready For A Second Look
The time may be right for FDA to revisit statins as a possible Rx-to-OTC switch category of drugs, according to Acting CDER Director Steve Galson, MD
CDER’s Galson Says Statin Switches May Be Ready For A Second Look
The time may be right for FDA to revisit statins as a possible Rx-to-OTC switch category of drugs, according to Acting CDER Director Steve Galson, MD