BioCentury | Aug 8, 2011
Clinical News

Axanum low dose aspirin/esomeprazole magnesium regulatory update

...in the EU and Norway issued a positive agreement for approval of an MAA for Axanum...
...last year under the EU's decentralized procedure, with Germany acting as the reference member state. Axanum...
...combination of low-dose aspirin and esomeprazole magnesium. Late last month, AstraZeneca withdrew an NDA for Axanum...
BioCentury | Aug 1, 2011
Clinical News

Axanum low dose aspirin/esomeprazole magnesium combination product regulatory update

...AstraZeneca withdrew an NDA for Axanum aspirin/esomeprazole to reduce the risk of low-dose aspirin-associated gastric and/or...
...low dose aspirin/esomeprazole magnesium combination product last year (see BioCentury, June 7, 2010). AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Axanum...
...last year (see BioCentury, June 7, 2010). AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Axanum low dose aspirin/esomeprazole magnesium combination product...
BioCentury | Jul 29, 2011
Financial News

AstraZeneca reports earnings

...revenues due to generic competition. On the regulatory front, the pharma withdrew an NDA for Axanum...
BioCentury | Jun 7, 2010
Clinical News

Axanum aspirin/esomeprazole magnesium regulatory update

...AstraZeneca submitted an MAA in Europe for Axanum aspirin/esomeprazole to prevent cardiovascular and cerebrovascular events in...
...with Germany acting as the reference member state. AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Axanum...
BioCentury | Jun 7, 2010
Clinical News

Axanum aspirin/esomeprazole magnesium regulatory update

...FDA issued a complete response letter for an NDA for Axanum aspirin/esomeprazole to reduce the risk...
...steps with FDA. Axanum is a low dose aspirin/esomeprazole magnesium combination product . AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Axanum...
BioCentury | Jun 4, 2010
Company News

AstraZeneca submits Axanum MAA

...AstraZeneca plc (LSE:AZN; NYSE:AZN) submitted an MAA in Europe for Axanum aspirin/esomeprazole to prevent cardiovascular and...
BioCentury | Jun 2, 2010
Company News

Axanum receives complete response

...FDA issued a complete response letter for an NDA from AstraZeneca plc (LSE:AZN; NYSE:AZN) for Axanum...
BioCentury | May 18, 2009
Clinical News

Low dose aspirin/esomeprazole magnesium combination product regulatory update

...AstraZeneca submitted an NDA to FDA for its low dose aspirin/esomeprazole magnesium combination product to reduce the risk of low dose...
...in patients at risk for developing gastric ulcers. AstraZeneca plc (LSE:AZN; NYSE:AZN), London, U.K. Product: Low dose aspirin/esomeprazole magnesium combination product...
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