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Durlaza 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 History and FDA Approval Process for Durlaza

DateArticle
Sep  8, 2015Approval FDA Approves Durlaza (aspirin) ER Capsules for Secondary Prevention of Stroke and Acute Cardiac Events

Further information

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