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...