Bayer pursuing chiral ibuprofen OTC status; NDAC, Arthritis review set for Oct. 9.
This article was originally published in The Tan Sheet
Executive Summary
S(+)IBUPROFEN TO BE REVIEWED BY NDAC AND ARTHRITIS ADVISORY COMMITTEE as an OTC analgesic in a one-day joint meeting scheduled for Oct. 9. If approved for OTC marketing, Bayer will market 200 mg S(+)ibuprofen -- the left isomer of racemate ibuprofen, which is also known as dexibuprofen -- under an undisclosed brandname currently being reviewed by FDA.