OTC Naproxen Labeling: US FDA Advisory Panel Finds Imprecise Direction In PRECISION
This article was originally published in The Pink Sheet & The Rose Sheet
Executive Summary
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.
You may also be interested in...
OTC Decisions In April: Naproxen CV Risk Warning, Sun US Line Rises, Perrigo Omeprazole 'Melt In Mouth' Flag
The first US approvals for adding cardiovascular risk warnings to OTC naproxenb products were for the Aleve line of multiple formulations and delivery formats and in multiple container sizes and Biopharma and Catalent 220-mg capsules. Sun Pharma extends into expectorant/allergy and diarrhea remedy spaces in US OTC market.
Celebrex Study Is Feel Good Story For Pfizer, But Are There Any Real Benefits?
Companies with pipeline pain products may see a smoother path through FDA, but Celebrex already has generic competition in the US, limiting the benefits even if it could get the black box removed from labeling and Pfizer also recently settled a lawsuit for $468 million related to the drug's safety.
NSAID Safety Review: FDA Panel Seeks Continued PRECISION From Pfizer
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.