Nexus Pharmaceuticals Inc. Receives FDA Approval for Tirofiban Hydrochloride Injection

2023-02-09
上市批准
LINCOLNSHIRE, Ill.--(BUSINESS WIRE)-- Nexus Pharmaceuticals, Inc. announced that it has received US Food and Drug Administration (FDA) approval for Tirofiban Hydrochloride Injection in 5mg/100mL single-dose IV-bags. Tentative approval has been granted for concentrations of 12.5mg/250mL single-dose IV-bags. It is an AP-rated generic to AGGRASTAT®¥. “We look forward to expanding our product range in the cardiovascular and IV solution space,” said Usman Ahmed, President and CEO. “Being granted this approval is a milestone for us, but also for patients who want more transparency in the healthcare they receive. We eagerly anticipate bringing it to market in the coming months.” Nexus PharmaceuticalsTirofiban Hydrochloride for Injection will be available in cartons of sole single-dose IV bags. About Tirofiban Hydrochloride for Injection Tirofiban Hydrochloride for Injection is indicated to reduce the rate of thrombotic cardiovascular events (combined endpoint of death, myocardial infarction, or refractory ischemia/repeat cardiac procedure) in patients with non-ST elevation acute coronary syndrome. For prescribing information, please see the following link. About Nexus Pharmaceuticals Inc. Nexus Pharmaceuticals Inc., a US-based healthcare company and certified diverse supplier, specializes in innovative processes to make difficult-to-manufacture specialty and generic drugs that are easier to use, less labor-intensive, and more streamlined in practice. Nexus ensures that its high-quality FDA-approved drugs fulfill a critical unmet medical need and delivers dependable life-saving treatment options when and where they’re needed most. For more information about Nexus Pharmaceuticals and its state-of-the-art manufacturing facility in Wisconsin, visit . ¥AGGRASTAT® is a registered trademark of Medicure Inc.
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