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news.Barr Pharmaceuticals has confirmed that its subsidiary, Barr Laboratories, has initiated a challenge of the patents listed by Azur Pharma International in connection with its FazaClo orally disintegrating tablets, 25mg and 100mg.
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The company believes that it is the first to file an abbreviated new drug application containing a paragraph IV certification for FazaClo.
Cima Labs and Azur Pharma and Azur Pharma International have previously filed a suit in the US District Court of Delaware to prevent Barr from proceeding with the commercialization of its product. This action formally initiates the patent challenge process under the Hatch-Waxman Act.