FDA's Patent-Based ANDA Exclusivity Policy Challenged By Apotex
This article was originally published in The Pink Sheet Daily
Executive Summary
Apotex files suit to force approval of its Prilosec ANDA, which is being held up by Andrx' exclusivity. Suit charges that FDA improperly granted Andrx additional period of exclusivity for omeprazole 40 mg based on a late-filed patent.