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Bayer approval

This article was originally published in The Tan Sheet

Executive Summary

Supplemental NDA 20-204/S-016 for Aleve 220 mg tablets, capsules and gelcaps cleared by FDA provides for "new vial for eight- and 12-count package sizes to be packaged by a new facility," as well as revised labeling for eight-count size. Labeling changes regarding font size, grammar should be "incorporated at the time of the next printing or in the final printed labeling," agency adds. Separately, Bayer announced it will cut 4,700 additional jobs by 2005, 40% of which will occur in Germany. Firm previously had announced plan to eliminate more than 10,000 jobs in the next four years...
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