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DRL files ANDA for Amlodipine Besylate

HYDERABAD: Dr. Reddy's Laboratories confirmed that it filed an Abbreviated New Drug Application (ANDA) with the U.S. 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. Following this, Pfizer filed a lawsuit against Dr. Reddy's alleging infringement on the two orange book patents. According to a release issued here on Tuesday, Amoldipine Besylate is the generic version of Pfizer's Norvasc and is indicated for the treatment of hypertension and angina. The brand had annual sales of about $2 billion, it said.

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