Durlaza FDA Approval History
FDA Approved: Yes (First approved September 4, 2015)
Brand name: Durlaza
Generic name: aspirin
Dosage form: Extended Release Capsules
Company: New Haven Pharmaceuticals, Inc.
Treatment for: Ischemic Stroke, Prophylaxis
Durlaza (aspirin) is a 24-hour, extended release aspirin formulation for the secondary prevention of stroke and acute cardiac events, including myocardial infarction (heart attack).Low-dose aspirin works by inhibiting platelet aggregation (blood clotting) and is a standard treatment for the prevention of stroke and heart attack in patients who have already had a stroke, heart attack, or other cardiovascular event. Traditional immediate-release aspirin formulations have a duration of action of four to six hours. Durlaza extends the release of aspirin utilizing extended-release, microcapsule technology offering 24-hour antiplatelet therapy. The capsules are taken once daily, and like immediate-release aspirin, can increase the risk of bleeding and gastric ulceration, and may cause fetal harm when administered to a pregnant woman.
Development Timeline for Durlaza
|Sep 8, 2015||FDA Approves Durlaza (aspirin) ER Capsules for Secondary Prevention of Stroke and Acute Cardiac Events|
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