May 04, 2009
NDA and supplemental NDA submitted for low dose aspirin/esomeprazole (Nexium) combinationsAstraZeneca announced the submission of a New Drug Application (NDA) to the FDA for the use of low dose aspirin with Nexium (esomeprazole magnesium) to reduce the risk of low dose aspirin-associated gastric and/or duodenal ulcers in patients at risk of cardio- and cerebrovascular events. AstraZeneca also submitted a supplemental new drug application (sNDA) for esomeprazole magnesium for the risk reduction of low dose aspirin-associated gastric and/or duodenal ulcers. Both the NDA and sNDA submissions are based on the results of two studies evaluating safety and efficacy of Nexium in patients who take low dose aspirin (75-325 mg continuously during the study, which is defined as at least 5 days per week).
Nexium is currently indicated to maintain symptom resolution and healing of erosive esophagitis (EE), for treatment of heartburn and other GERD symptoms, and for short-term (4 to 8 weeks) healing and symptomatic resolution of diagnostically confirmed EE.
For more information call (800) 237-8898 or visit www.astrazeneca-us.com.