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FDA accepts filing of The Medicines Co's new drug application for intravenous antibiotic oritavancin with priority review


Wednesday, 19 Feb 2014 06:30am EST 

The Medicines Co:Says that the U.S. Food and Drug Administration (FDA) has accepted the filing of a new drug application (NDA) for oritavancin, an investigational intravenous antibiotic, with priority review.Says it is seeking approval of oritavancin for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by susceptible gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), administered as a single dose.In December 2013, the FDA designated oritavancin as a Qualified Infectious Disease Product (QIDP).The QIDP designation provides oritavancin priority review, and an additional five years of exclusivity upon approval of the product for the treatment of ABSSSI.Priority review means the FDA's goal is to take action on the application within six months, compared to 10 months under standard review. The FDA action date (PDUFA date) for oritavancin is August 6, 2014. 

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19 Dec 2014