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Ibuprofen NDA approval

This article was originally published in The Tan Sheet

Executive Summary

Banner Pharmacaps' 505(b)(2) application (NDA 21-472) for ibuprofen 200 mg softgels approved by FDA Oct. 18. Product carries same indication as Wyeth's Advil Liqui-Gels. Banner says 505(b)(2) filing was necessary because there is no approved OTC ibuprofen with same dosage form and same active ingredient that would have allowed an ANDA filing. Advil Liqui-Gels have the same pharmacokinetic profile but contain partially titrated potassium salt of ibuprofen. Banner's product uses the free acid form of ibuprofen - the same as that found in standard ibuprofen tablets, caplets - but offers a different delivery form. Banner plans to partner with other firms to bring newly approved version to market...

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