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Dr. Reddy's files ANDA with USFDA
HYDERABAD: Dr. Reddy's Laboratories announced it had filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (USFDA) for Levetiracetam tablets, 250, 500 and 750 mg, with a Paragraph IV certification on the two Orange Book patents listed for the drug.
According to a press release, Dr. Reddy's notified UCB, upon which the latter filed a lawsuit against the company in the U.S. District Court for the District of Georgia, alleging patent infringement on the two Orange Book patents. Levetiracetam is the generic version of UCB's KeppraTM and is indicated for the treatment of epilepsy.
The brand had annual sales in the United States of approximately $234 million (Source: IMS MAT September 2003).
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