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

NDAC joint panel planned

This article was originally published in The Tan Sheet

Executive Summary

FDA's drug center has tentatively scheduled a joint meeting of its Endocrinologic and Metabolic Drugs Advisory Committee and its Nonprescription Drugs Advisory Committee for Dec. 13 and 14. The agency will not discuss the planned topic until publishing a Federal Register notice announcing a confirmed meeting. Previously, the agency convened the same joint panel to consider the suitability of statins, including Merck's Mevacor (lovastatin) and Bristol-Myers Squibb's Pravachol (pravastatin) for OTC sale, and to review GlaxoSmithKline's weight-loss drug alli (orlistat) for an Rx-to-OTC switch. Bayer, which now holds the OTC rights for Pravachol, is pursuing an active program to switch the drug to OTC, while J&J/Merck is still seeking a switch for Mevacor (1"The Tan Sheet" July 2, 2007, In Brief)...
Advertisement

Related Content

Topics

Advertisement
UsernamePublicRestriction

Register

PS100912

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