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Breckenridge's ANDA for oxcarbazepine gets US FDA approval
Boca Raton, Florida | Tuesday, January 15, 2008, 08:00 Hrs  [IST]

Breckenridge Pharmaceutical, Inc. said the US Food and Drug Administration approved Breckenridge's Abbreviated New Drug Application for oxcarbazepine, a generic version of Novartis' seizure drug Trileptal in the United States. The company has also settled a Paragraph IV litigation with Novartis concerning the drug.

Breckenridge will have a shared 180-day exclusivity period and will immediately launch Oxcarbazepine tablets 150 mg, 300 mg, and 600 mg. Oxcarbazepine tablets are AB rated to Trileptal, a $600 million brand name drug marketed by Novartis Pharmaceuticals Corporation, and are used in treating seizures.

Breckenridge is actively seeking development and marketing alliances with domestic and foreign companies for generic and branded pharmaceuticals. Breckenridge products are contract manufactured through partnerships with pharmaceutical manufacturers in state-of-the-art facilities throughout the US. Breckenridge maintains a stringent Quality Assurance program to ensure a consistent supply of quality pharmaceutical products.

Breckenridge Pharmaceutical, Inc., a privately-held pharmaceutical marketing research and development company founded in 1983, is headquartered in Boca Raton, Florida, which markets over 100 products in many therapeutic categories to over 100 customers in all classes of trade.

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