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

CDER’s Galson Says Statin Switches May Be Ready For A Second Look

This article was originally published in The Tan Sheet

Executive Summary

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

You may also be interested in...



FDA’s Crawford Backs Away From Forced Antihistamine Switch Controversy

FDA says it would like to "stimulate" Rx-to-OTC switches where appropriate, but not "force" the policy on drug makers

Pravachol OTC Label Studies, Redefined Population Urged By Cmte.

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.

People In Brief

Perrigo promotes in pricing, planning

Topics

UsernamePublicRestriction

Register

PS096793

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

Cancel