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FDA accepts Duramed’s Lo Seasonique NDA

Duramed Pharmaceuticals, a subsidiary of Barr Pharmaceuticals has reported that the FDA has accepted for review its new drug application or NDA for Lo Seasonique extended-cycle oral contraceptive.

The company is seeking approval to manufacture and market the Lo Seasonique for the prevention of pregnancy. The Prescription Drug User Fee Action (PDUFA) date for the Lo Seasonique NDA is October 24, 2008.