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Yosprala Approval History

FDA Approved: Yes (First approved September 14, 2016)
Brand name: Yosprala
Generic name: aspirin and omeprazole
Dosage form: Delayed-Release Tablets
Company: Aralez Pharmaceuticals Inc.
Treatment for: Ischemic Stroke, Prophylaxis, Gastric Ulcer Prophylaxis

Yosprala (aspirin and omeprazole) is a platelet aggregation inhibitor and proton pump inhibitor combination indicated for patients who require aspirin for secondary prevention of cardiovascular (CV) and cerebrovascular events and who are at risk of developing aspirin associated gastric ulcers.

Development History and FDA Approval Process for Yosprala

DateArticle
Sep 15, 2016Approval FDA Approves Yosprala (aspirin and omeprazole) for Secondary Prevention of Cardiovascular Disease in Patients at Risk for Aspirin-Associated Gastric Ulcers
Mar 15, 2016Aralez Resubmits to FDA New Drug Application for Yosprala
Dec 17, 2014Pozen’s Yosprala Receives Complete Response Letter from the FDA

Further information

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