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

OTC NSAIDs Need Additional Label Warnings – FDA Advisory Panel

This article was originally published in The Tan Sheet

Executive Summary

Labels for OTC NSAIDS need additional information about potential risks, say panel members in a joint meeting of the Arthritis and the Drug Safety and Risk Management advisory committees. Data do not show naproxen has a lower CV thrombotic event risk compared to other NSAIDs, they say.

You may also be interested in...



NSAID Panel Could Give Naproxen Labeling Edge

FDA’s Arthritis and Drug Safety and Risk Management advisory committees on Feb. 10-11 will examine cardiovascular risk data for non-steroidal anti-inflammatory drugs, including meta-analyses indicating naproxen could have a better safety profile than other OTC ingredients ibuprofen and ketoprofen.

Ultrahuman Expands Wearable Medtech Production Into US After $35M Funding Round

Firm operating in London, India and United Arab Emirates says its “Ultra Factory” will open in Indiana within the next six months with end-to-end production based on its operational facility in India.

California Bill To Age-Restrict Sales Of Diet Pills Further Along Than Other States’ Legislation

CA, MA and NJ legislatures remain in session with bills active proposing regulations similar to NY law effective 22 April requiring retailers, including online, to ask for proof of age when customers buying consumer health products containing ingredients labeled or promoted for weight loss and bodybuilding benefits appear younger than 18.

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

PS107380

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