FDA Ordered To Rescind Barr's 180-Day Exclusivity For Generic Tamoxifen
Executive Summary
FDA is ordered to reverse its March 1999 decision to grant Barr's tamoxifen 180-day exclusivity by Washington, D.C. federal court on the grounds that Barr lost its first ANDA filer status when it dropped its patent challenge in a settlement with tamoxifen innovator AstraZeneca.
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