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Dr Reddy's files drug application with USFDA

Our Bureau

Hyderabad , Feb. 24

DR Reddy's Laboratories Ltd on Tuesday announced that it had filed an abbreviated new drug application (ANDA) with the US Food and Drug Administration (USFDA) for amlodipine besylate tablets 2.5, 5 and 10 mg, with a paragraph-IV certification on the two Orange Book patents listed for the drug.

In a press release, Dr Reddy's said it had notified Pfizer, upon which the latter filed a lawsuit against the company in the US District Court for the district of New York alleging patent infringement on the two Orange Book patents.

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