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

J&J/McNeil Consent Decree Prequel Tops OTC Stories, Switch Leads Topics In 2014

This article was originally published in The Tan Sheet

Executive Summary

“The Tan Sheet” readers also made top stories of FDA’s rejection of Bayer’s petition for aspirin as primary prevention of heart attack stroke; advisors recommending FDA consider additional label warnings for OTC NSAIDS; and FDA seeking to overhaul its OTC drug monograph process to be “more agile and responsive.”

You may also be interested in...



J&J Bit Off More Than McNeil Could Chew In 2006 Pfizer OTC Acquisition

McNeil scaled up its manufacturing “volume and complexity substantially” following J&J’s acquisition of Pfizer’s consumer business in 2006, says McNeil Consumer VP Shane Freedman. “Just a few years later, we had the recalls” that led eventually to a consent decree with FDA,” he says.

Chronic Conditions Data Emphasize Need For Additional, Innovative OTCs

An NIH-funded study shows 92% of older consumers have chronic conditions, the primary target of FDA’s Nonprescription Safe Use Regulatory Expansion initiative to facilitate more Rx-to-OTC switches. The agency also extends the comment period for its initiative on making more ingredients available through the OTC monograph process.

Merck Singulair Switch NDA Limits Indication to Allergies, Omits Asthma

Merck will try to convince an FDA advisory committee May 2 to partially switch its blockbuster Rx drug Singulair to OTC for allergy relief in adults only. The firm will not seek to switch the Rx indications for asthma or allergy relief in children.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS107418

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