Banner naproxen petition
This article was originally published in The Tan Sheet
Executive Summary
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)...