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

Mevacor Daily OTC Switch Rejected Based On Patient Inability To Self Select

This article was originally published in The Pink Sheet Daily

Executive Summary

FDA joint committee finds that current system does not ensure appropriate patient self-selection for cholesterol-lowering therapy. Committee votes 20-3 against OTC marketing for Mevacor Daily. Behind-the-counter strategy for pharmacy urged.

You may also be interested in...



J&J/Merck's Mevacor OTC Switch Appears To Be "Not Approvable" At FDA

Merck's receipt of a letter from FDA on the eve of the Feb. 24 user fee deadline, coupled with statements from the agency, suggest that FDA deemed the statin "not approvable" for OTC sale. Advisory committees voted against the switch in January.

J&J/Merck's Mevacor OTC Switch Appears To Be "Not Approvable" At FDA

Merck's receipt of a letter from FDA on the eve of the Feb. 24 user fee deadline, coupled with statements from the agency, suggest that FDA deemed the statin "not approvable" for OTC sale. Advisory committees voted against the switch in January.

FDAers Sink Mevacor OTC At Panel Meeting With Unflinching Critique

Presentations by FDA OTC division cast Johnson & Johnson/Merck Mevacor OTC studies in negative light during advisory committee meeting. FDAers cite low rates of proper self-selection, comprehension for CUSTOM actual-use study.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS060868

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