DRL files ANDA for Rabeprazole Sodium

By SiliconIndia   |   Thursday, 20 November 2003, 08:00 Hrs
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HYDERABAD: Dr. Reddy's Laboratories today filed an Abbreviated New Drug Application (ANDA) with the US Food and Drug Administration (FDA). The ANDAv was filed for Rabeprazole Sodium delayed-release tablets, 20 mg, with a Paragraph IV certification on the two Orange Book patents listed for the drug.

Dr. Reddy's notified Eisai, upon which the latter filed a lawsuit against the company in the United States District Court for the southern district of New York alleging patent infringement on the '552 patent, the release issued to the BSE said.

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