Business - Monitor

Dr. Reddy's files ANDA with U.S. FDA

HYDERABAD: Dr. Reddy's Laboratories has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for Clopidogrel Bisulfate tablets 75 mg with para IV certification on all listed orange book patents. According to a release, Dr. Reddy's notified Sanofi-Synthelabo Inc, upon which the latter filed a lawsuit against the company alleging patent infringement. Clopidogrel Bisulfate is the generic version of Sanofi-Synthelabo's Plavix.

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