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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

Jun  1, 2010AstraZeneca Receives FDA Complete Response Letter for Axanum New Drug Application
May  4, 2009AstraZeneca Submits NDA for Low Dose Aspirin/Esomeprazole Combination Product

Further information

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