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Medicure Announces Approval of Expanded Dosing Time For Aggrastat

Posted 23 Apr 2015 by Drugs.com

WINNIPEG, April 23, 2015 /PRNewswire/ - Medicure Inc. ("Medicure" or the "Company") (TSXV:MPH, OTC:MCUJF), a specialty pharmaceutical company, is pleased to announce that the United States Food and Drug Administration (FDA) has approved a revision to the duration of the bolus delivery for the Aggrastat (tirofiban HCl) high-dose bolus (HDB) regimen. The dosing change and label modification was requested by the Company to help health care professionals more efficiently meet patient-specific administration needs and to optimize the implementation of Aggrastat at new hospitals. The newly approved labeling supplement now allows the delivery duration of the Aggrastat high-dose bolus (25 mcg/kg) to occur anytime within 5 minutes, instead of the previously specified duration of 3 minutes. This change is part of Medicure's ongoing regulatory strategy to expand the applications for Aggrastat. ... Read more

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