Skip to Content

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

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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.