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


Approvals For Stronger NSAIDs Label Warning About Risks During Late Pregnancy Begin In US

Executive Summary

FDA since late October has sent approvals to firms which had submitted proposals for updates under the “If pregnant or breast-feeding” warning on their OTC NDAID DFls. First approval, dated 21 October, went to Bionpharma for its 200-mg ibuprofen tablets it provides for private label and store brand customers.

You may also be interested in...

EU Regulatory News Round Up: NSAIDs During Pregnancy, Estragole Excipients, ePIs

CMDh receives applications to change how NSAIDs are recommended for use during pregnancy; HMPC warns against use of estragole-containing excipients in herbals; EMA adopts new EU common standard for electronic product information on medicines marketed within the region.

NSAIDs Marketed In US Will Have Stronger Label Warning About Risks During Late Pregnancy

In Drug Safety Communication, FDA says it is requiring labeling changes for Rx as well as OTC NSAIDs due to risk of rare but serious kidney problems in an unborn baby.

FDA Wants Stronger Cardiovascular Warning For OTC NSAIDs

The agency says it will require stronger warnings about cardiovascular risks on prescription NSAIDS’ Drug Facts labels, but will request that OTC NSAID labels also are changed.


Latest News
See All



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