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This article was originally published in The Tan Sheet

Executive Summary

Files ANDA suitability petition March 22 for "solubilized" ibuprofen - a.k.a. Whitehall's Advil Liqui-Gels. Knoll's proposed branded ibuprofen product would differ from the reference drug in that it would be in tablet form, processed from a solid, "extruded" form of the liquid ibuprofen solution used in the currently marketed soft gel product. The firm's petition includes data showing what Knoll describes as "substantial equivalence" between the proposed ibuprofen product, Advil Liqui-Gels and two other ibuprofen products. The new tablet is said to have faster absorption than standard ibuprofen tablets, similar to the liquid gel product. Knoll has published for third-party review a variety of trademarks for pharmaceuticals and dietary supplements manufactured using "melt extrusion" technology

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