Axanum Approval Status
- FDA approved: No
- Brand name: Axanum
- Generic name: aspirin and esomeprazole
- Company: AstraZeneca
- Treatment for: NSAID-Induced Ulcer Prophylaxis, Ischemic Stroke, Prophylaxis
Axanum (aspirin/esomeprazole) is an investigational low dose aspirin esomeprazole combination for the risk reduction of low dose aspirin-associated gastric and/or duodenal ulcers.
In June 2010, AstraZeneca announced the receipt of a Complete Response Letter from the U.S. Food and Drug Administration (FDA), advising the company that the New Drug Application (NDA) for Axanum (aspirin/esomeprazole magnesium) tablets had not been approved.
Development Status and FDA Approval Process for Axanum
|Jun 1, 2010||AstraZeneca Receives FDA Complete Response Letter for Axanum New Drug Application|
|May 4, 2009||AstraZeneca Submits NDA for Low Dose Aspirin/Esomeprazole Combination Product|
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