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S(+)ibuprofen proposed labeling identical to existing ibuprofen products.

This article was originally published in The Tan Sheet

Executive Summary

BAYER S(+)IBUPROFEN PROPOSED LABELING IDENTICAL TO IBUPROFEN product labeling on the market, the firm told an Oct. 9 joint meeting of the FDA Nonprescription Drugs and Arthritis Drugs Advisory Committees in Bethesda, Md. Bayer plans to use the "Drug Facts" format for S(+)ibuprofen (dexibuprofen) labeling, with the same directions and warnings as existing ibuprofen products. The package also would contain a consumer education leaflet and display a toll-free number for inquiries. The committee voted not to recommend approval for the NDA for dexibuprofen OTC marketing.
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