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Andrx Generic Tiazac Open For Approval; Court Lifts 30-Month Stay

Executive Summary

The stay of approval on Andrx' generic version of Biovail/Forest's Tiazac (diltiazem) will be lifted Sept. 27, Miami federal court Judge William Dimitrouleas ruled Sept. 19.

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Generic Stay May Be Shortened Based Only On Behavior In Trial – Appeals Court

The 30-month stay of approval on generic products may be shortened if the brand firm delays responding to a patent infringement action, but not for delays in the resolution of the overall patent dispute, the Court of Appeals for the Federal Circuit found

Generic Stay May Be Shortened Based Only On Behavior In Trial – Appeals Court

The 30-month stay of approval on generic products may be shortened if the brand firm delays responding to a patent infringement action, but not for delays in the resolution of the overall patent dispute, the Court of Appeals for the Federal Circuit found

Biovail v. Andrx

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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