Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

NSAID Safety Review: FDA Panel Seeks Continued PRECISION From Pfizer

This article was originally published in The Pink Sheet Daily

Executive Summary

Pfizer’s long-term safety outcome study comparing Celebrex, ibuprofen and naproxen has its flaws, but FDA advisory committee says its data will be far superior to meta-analyses or observational studies.

You may also be interested in...



OTC Naproxen Labeling: US FDA Advisory Panel Finds Imprecise Direction In PRECISION

Safety study of celecoxib vs. ibuprofen and naproxen spurs advisory committees to recommend adding aspirin-interaction warning on OTC naproxen labels, but many panelist made clear that PRECISION results had not swayed their thinking on celecoxib CV safety or on the OTC ingredients' interaction with aspirin.

OTC Naproxen Labeling: US FDA Advisory Panel Finds Imprecise Direction In PRECISION

Safety study of celecoxib vs. ibuprofen and naproxen spurs advisory committees to recommend adding aspirin-interaction warning on OTC naproxen labels, but many panelist made clear that PRECISION results had not swayed their thinking on celecoxib CV safety or on the OTC ingredients' interaction with aspirin.

NSAID Comparative Safety: PRECISION Study, FDA Pertinacity … And Anti-Clotting Agents?

US FDA's planned advisory committee on comparative safety in the NSAID/COX inhibitor area shows agency's staying power on safety issues.  

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

LL1133833

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

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