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February 27, 2014
08:50 EDTMDCOThe Medicines Co. announces EMA accepts MAA for oritavancin
The Medicines Company announced that the European Medicines Agency has accepted for review a marketing authorization application for the investigational intravenous antibiotic, oritavancin, for the treatment of complicated skin and skin tissue infections caused by susceptible gram-positive bacteria, including by methicillin-resistant Staphylococcus aureus, administered as a single dose. The oritavancin MAA is based on data from two Phase 3 clinical trials, SOLO I and SOLO II. These Phase 3 trials evaluated the efficacy and safety of a single 1200 mg dose of oritavancin compared to 7 to 10 days of twice-daily vancomycin in adults with cSSTI, including infections caused by MRSA. The combined SOLO studies were conducted in 1,959 patients with 405 of the patients suffering from a cSSTI with a documented MRSA infection. The acceptance of the MAA marks the beginning of the review process in the European Union for oritavancin. Oritavancin is also under review by the US Food and Drug Administration in the U.S.
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November 20, 2015
12:02 EDTMDCOThe Medicines Co. receives EC approval for IONSYS
The Medicines Company announced that the European Commission has granted marketing authorization for IONSYS(40 micrograms per dose transdermal system), with active ingredient fentanyl, for the management of acute moderate-to-severe, post-operative pain in adult patients for use in the hospital. IONSYS will be the only needle-free, patient-controlled, pre-programmed iontophoretic transdermal delivery system for use in adult patients requiring opioid analgesia in EU hospital settings. The marketing authorization follows the issuance of a positive opinion in September by the Committee for Medicinal Products for Human Use of the European Medicines Agency and is now valid in the 31 countries of the European Economic Area, which includes all 28 European Union Member States, plus Norway, Iceland and Liechtenstein. A supplemental new drug application for IONSYS was approved by the U.S. FDA in April 2015 with an approved IONSYS Risk Evaluation Mitigation Strategy program. The product is commercially available in the U.S. as of July 2015.

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