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Biovail v. Andrx

Executive Summary

Andrx may "sue the FDA directly under the [administrative procedure act] to compel the FDA to approve" its diltiazem ANDA (Taztia XT), the D.C. federal appeals court says in reversing a Miami federal district court decision lifting the 30-month stay on approval of generic versions of Biovail's Tiazac (1"The Pink Sheet" Sept. 24, 2001, p. 12). The patent infringement trial is scheduled for June 3...

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