Axanum FDA 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 timeline for Axanum
| Date | Article |
|---|---|
| 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 |
Further information
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