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

Hemwall on Mevacor

This article was originally published in The Tan Sheet

Executive Summary

"I really don't want to read any more in 'The Tan Sheet' once a week about the 20-3 vote on the approvability question" regarding the proposed Rx-to-OTC switch of 20 mg Mevacor, J&J/Merck VP-Scientific & Regulatory Affairs Ed Hemwall quipped during the Consumer Healthcare Products Association's Regulatory & Scientific Conference in Washington, D.C. May 5. Hemwall spoke at the FDA advisory committee meeting on the switch application in January (1"The Tan Sheet" Jan. 17, 2005, p. 3). Despite the panel's recommendation against approval, the sponsor "made a lot of very good progress," Hemwall said. "We also had several 25-0 votes on major safety and efficacy issues," such as muscle and liver safety and drug interactions, he noted. "It [comes back to] understanding consumer behavior...that's the final piece of information that's going to be needed if a drug of this type is ever going to switch"...

You may also be interested in...



Mevacor OTC Panel Rejection Elicits Third Drug Class Talk

A joint FDA panel decision to recommend against approval of over-the-counter Mevacor Daily was tempered by the endorsement of a behind-the-counter drug class by a number of panelists

Are Regulators Ready For The Robot Era? ChatGPT Weighs In On EU Regulation

Artificial intelligence model’s comments signal the likely start of computer-generated comments to the US FDA’s public notices.

Pink Sheet Podcast: US FDA Loses Gene Therapy Expert, Humira Biosimilars Launch, FDA Allows In-Person Meetings

Pink Sheet reporters and editors consider the impact of FDA Office of Tissues and Advanced Therapies Director Wilson Bryan’s retirement, the launch of Humira biosimilars and its effect on the biologic market, as well as the FDA moving to hybrid meetings with sponsors.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS098170

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