Medicure Inc., 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 hydrochloride) 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.
For more details, go to: http://www.medicure.com/news04232015.html