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Medicure Files Application for New AGGRASTAT® Product Format
Medicure Files Application for New AGGRASTAT® Product Format Medicure Files A...
About this update from Medicure Inc.
[{"type":"text","content":"\n\n\n\nMedicure Files Application for New AGGRASTAT® Product Format\n\n/* Style Definitions */\nspan.prnews_span\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\na.prnews_a\n{\ncolor:blue;\n}\nli.prnews_li\n{\nfont-size:8pt;\nfont-family:\"Arial\";\ncolor:black;\n}\np.prnews_p\n{\nfont-size:0.62em;\nfont-family:\"Arial\";\ncolor:black;\nmargin:0in;\n}\n.prntac{\nTEXT-ALIGN: CENTER\n}\n\n\n\n\n\n\nMedicure Files Application for New AGGRASTAT® Product Format\nCanada NewsWire\nWINNIPEG, May 11, 2016\n\n\n\nExpects to Launch Bolus Vial in Q3 2016 \n\n\n\nWINNIPEG, May 11, 2016 /CNW/ - Medicure Inc. (\"Medicure\" or the \"Company\") (TSXV:MPH, OTC:MCUJF), a specialty pharmaceutical company, is pleased to announce that it has submitted an application to the U.S. Food and Drug Administration (FDA) for the introduction of a new \"bolus vial\" product format for AGGRASTAT (tirofiban HCl).  \n\nThe new product format is a concentrated, pre-mixed, 15 ml vial containing sufficient drug to administer the FDA approved, high dose bolus (HDB) of 25 mcg/kg at the beginning of treatment. AGGRASTAT is currently only sold in a pre-mixed intravenous bag format that comes in two sizes, 100 ml and 250 ml.  The existing, pre-mixed products will continue to be available, providing a convenient concentration for administering the post-HDB maintenance infusion of 0.15 mcg/kg/min.  (Approved Dosing: Administer intravenously 25 mcg/kg within 5 minutes and then 0.15 mcg/kg/min for up to 18 hours.)\n\n\"Our decision to pursue the new bolus vial format is in response to feedback we have received from hospitals considering a switch to AGGRASTAT,\" stated Dr. Albert Friesen, Chief Executive Officer and President at Medicure Inc. \"If the application is approved, we anticipate the launch of the new product format in Q3 2016, and we expect that this investment in our brand will make a significant contribution as we seek to further expand use of AGGRASTAT across the United States.\"\n\nAlthough the current bag format can be used to deliver the HDB as well as the maintenance infusion, some physicians and hospital catheterization labs prefer to administer the initial bolus dose with a smaller volume of drug product.  Moreover, the availability of a ready-to-use bolus vial will provide greater operational similarities and eff...