HBW Insight 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

Pediatric CVD Report Slights Nutrition’s Role, Weighs On OTC Statin Chances

This article was originally published in The Tan Sheet

Executive Summary

An American Academy of Pediatrics report recommending prescribing statin drugs for cardiovascular disease in children could present another roadblock for switching statins to OTC

You may also be interested in...



Placebo Causes Adverse Reaction With Industry, Raises Regulatory Concerns

An inert sugar pill marketed as a placebo for ailing children will likely attract regulatory interest from the Federal Trade Commission as well as FDA, according to industry experts

Merck’s Mevacor not approved

FDA found Merck's third Rx-to-OTC switch application for OTC cholesterol-lowering Mevacor Daily (lovastatin/20mg) "not approvable." In a Jan. 25 release, the firm said FDA's letter responding to its application indicated the drug's approval would require "a revised label and additional data from Merck in order to gain marketing approval." "We are evaluating the conditions put forth by the agency in the letter to determine a path forward, and no decision is made at this time for the future of our Mevacor efforts," a spokesman forthe Whitehouse, N.J.-based firm told "The Tan Sheet." At a Dec. 13 meeting, FDA advisory committees recommended against approving the switch. The firm was also unsuccessful in gaining OTC approval for the drug in 2000 and 2005.....

FDA Advisors Say Greater Insight Needed On Self-Selection Of OTC Statins

More information from "real world" experiences on how consumers make OTC selections may be needed to pull off a successful Rx-to-OTC switch of a statin

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

RS137359

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