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


NSAID labeling cost projection grows

This article was originally published in The Tan Sheet

Executive Summary

FDA raises its estimate of industry costs in a final rule requiring organ-specific label warnings for OTC products containing acetaminophen or nonsteroidal anti-inflammatory drugs by April 29, 2010. The revised rulemaking bumps up first-year, one-time, industry-wide re-labeling costs to $62.7 million from $32.6 million, according to a June 30 Federal Register notice. FDA says its April 29 estimate of the products affected by the final rule underestimated the proportion of affected NSAID products, which will need expanded inner blister pack containers and outer cartons to accommodate the additional warnings. Packaging for OTC acetaminophen will not need to be made larger, FDA says. FDA still projects the total number of SKUs affected at 18,000, while industry consultant Eastern Research Group says it could be as high as 25,000 (1"The Tan Sheet" May 4, 2009)

You may also be interested in...

FDA Expands Acetaminophen, NSAID Labeling Beyond Tentative Final Rule

FDA's final rule for OTC products containing acetaminophen or nonsteroidal anti-inflammatory drugs requires warnings and revisions that go beyond changes the agency proposed in a 2006 tentative final rule

Boost For Oral SERDs As Menarini/Radius’ Orserdu Becomes First Approved For Breast Cancer

The firms’ Orserdu has won a US thumbs up for the treatment of ESR1-mutated advanced or metastatic breast cancer, marking a positive breakthrough for the challenging SERD drug class.

Pfizer In Pole Position To Benefit From Novartis Sickle Cell Drug Setback

Pfizer joined Novartis as the market leader in sickle cell disease when it acquired Global Blood Therapeutics last year. The US giant's Oxbryta may now move ahead following a clinical and regulatory setback for the Swiss major's Adakveo.


Latest Headlines
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