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February 27, 2014
07:40 EDTCBSTCubist announces EMA acceptance of Tedizolid MAA for review
Cubist Pharmaceuticals announced that the European Medicines Agency has accepted for review the company’s Marketing Authorization Application, or MAA, for its investigational antibiotic tedizolid phosphate. Cubist is seeking approval of tedizolid for the treatment of complicated skin and soft tissue infections, with a decision from the European Commission expected during the first half of 2015. Tedizolid is a once daily oxazolidinone being developed for both intravenous and oral administration for the treatment of serious infections caused by certain Gram-positive bacteria, including those caused by methicillin-resistant Staphylococcus aureus. The MAA submission is based on positive data from two global Phase 3 clinical studies of tedizolid, which met the primary and secondary endpoints defined by the EMA and U.S. Food and Drug Administration.
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