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

Merck’s Mevacor not approved

This article was originally published in The Tan Sheet

Executive Summary

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.....

You may also be interested in...



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

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

FDA Rules Insufficient For Statins, Chronic Switches – Former NDAC Chair

Future attempts to switch drugs for chronic, asymptomatic conditions to OTC status could be stymied unless new authorities are granted to FDA, says the chairwoman who oversaw the most recent Nonprescription Drugs Advisory Committee meeting to review a statin switch application

Abbott Capitalizes On Pandemic Testing Boom; Device Sales Stay Almost Flat

Abbott reported almost 28% revenue growth in the fourth quarter led by the exploding demand for COVID-19 tests and continued success of its FreeStyle Libre continuous glucose monitor.

Topics

UsernamePublicRestriction

Register

LL1129552

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