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.

A methyl salicylate transdermal patch and a topical with an ingredient made available nonprescription in the US in 2020 are among the first OTC nonsteroidal anti-inflammatory drugs re-labeled to more strongly warn against use during pregnancy or while nursing.

The Food and Drug Administration’s Center for Drug Evaluation and Research since late October has sent approvals to firms which...