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Durlaza Approval History

  • FDA approved: Yes (First approved September 4th, 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

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