FDA Wants Stronger Cardiovascular Warning For OTC NSAIDs
This article was originally published in The Tan Sheet
Executive Summary
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.
You may also be interested in...
Approvals For Stronger NSAIDs Label Warning About Risks During Late Pregnancy Begin In US
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.
US OTC Decisions In July: Labeling For Advil Sinus In 2-Count Packages, Lansoprazole, Ibuprofen
Total of approvals for label changes for three OTC products in July equals the number CDER made for nonprescription products in the same month in 2019. July updates include approval of an sNDA for labeling for Advil Sinus Congestion & Pain tablets in packages containing two single-tablet pouches.
Jurors' Answers In FTC's Prevagen Complaint Might Burst A Memory Bubble For Health Claims
“No” answers in New York federal court on whether all but two of Prevagen claims were “materially misleading” could put a fork in the road of a long dispute between FTC and supplement product manufacturers and marketers.