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DRL files ANDA for Fexofenadine HCL

HYDERABAD: Dr. Reddy's Laboratories has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration for Fexofenadine HCL tablets, equivalent to 30mg, 60mg and 180mg of base, with Paragraph IV certifications on all seven orange books patents listed for Allegra tablets. The company notified Aventis Pharmaceuticals, upon which the latter filed a lawsuit against Dr. Reddy's in the U.S. District Court of New Jersey, alleging infringement of six orange book patents, according to a release.

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