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Banner naproxen petition

This article was originally published in The Tan Sheet

Executive Summary

Banner Pharmacaps requests FDA allow filing of ANDA for naproxen sodium softgel capsules with same indication as Bayer's Aleve but different dosage form. In recent citizen petition to agency, Banner notes proposed naproxen softgel contains same active ingredient, same strength and same route of administration as Aleve tablets, will be labeled with same conditions of use but will differ with respect to dosage form, inactive ingredients and manufacturer contact information. High Point, N.C.-based firm recently received FDA approval for softgel version of Wyeth's Advil Liqui-Gels (1"The Tan Sheet" Oct. 28, 2002, In Brief). Leiner will package, market the 200 mg ibuprofen softgels in 20-, 40-, 80-, 135-, 200-count packages, as well as twinpacks of the 135-count for club outlets, generic firm says Nov. 14...

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Banner naproxen petition

FDA grants Banner Pharmacaps permission to file ANDA for naproxen sodium 220 mg capsules with same indication as Bayer's Aleve tablets but different dosage form. In Feb. 25 letter, agency finds "change in dosage form for the specific proposed drug product does not pose questions of safety or effectiveness because the uses, dose and route of administration...are the same as that of the listed drug product." However, FDA notes "approval of this petition to allow an ANDA to be submitted" does not necessarily mean ANDA will be approved. Banner submitted petition in November, has received approval for softgel version of Advil Liqui-Gels (1"The Tan Sheet" Nov. 18, 2002, In Brief)...

Ibuprofen NDA approval

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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