AstraZeneca Submits NDA for Aspirin/Nexium Product


AstraZeneca submitted an NDA to the FDA seeking approval for low-dose aspirin combined with esomeprazole magnesium (Nexium) to reduce the risk of low-dose aspirin-associated side effects, such as gastric and/or duodenal ulcers.

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By: Tim Wright

Editor-in-Chief, Contract Pharma

AstraZeneca submitted an NDA to the FDA seeking approval for low-dose aspirin combined with esomeprazole magnesium (Nexium) to reduce the risk of low-dose aspirin-associated side effects, such as gastric and/or duodenal ulcers. AstraZeneca also submitted a sNDA for Nexium for the risk reduction of low-dose aspirin-associated gastric and/or duodenal ulcers. Nexium is approved for the risk reduction of gastric ulcers associated with continuous non-steroidal anti-inflammatory drug (NSAID) therap...

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