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Federal Circuit Affirms Preliminary Injunction Against Apotex's Generic Version of Pulmicort Respules

By Aaron Barkoff

AstraZeneca v. Apotex, No. 2009-1381 (Fed. Cir. 2010) by Andrew W. Williams On Monday, the Federal Circuit affirmed a preliminary injunction granted by the U.S. District Court for the District of New Jersey barring Apotex from launching a generic version of Pulmicort Respules, a budesonide drug made and sold by AstraZeneca.  Apotex gained FDA approval of its generic drug product after filing an ANDA with a section viii statement, asserting that it was not seeking approval for once-daily read more

Full post as published by Orange Book Blog: At the Intersection of Patent Law and FDA Law on November 03, 2010 (boomark / email).