Axanum is a fixed-dose combination containing low-dose acetylsalicylic acid and the active ingredient of Nexium for the prevention of cardio- and cerebrovascular events in patients requiring continuous low-dose ASA treatment and at risk for developing ASA associated gastric and/or duodenal ulcers. The company is currently in discussions with the FDA regarding next steps for the drug, according to the release.
The FDA also rejected a supplemental new drug for Nexium, which was submitted for the risk reduction of low-dose aspirin-associated peptic ulcers.
Read the release on AstraZeneca’s CRLs for Axanum and Nexium.
At the Becker’s 32nd Annual Meeting: The Business and Operations of ASCs, taking place October 29-31 in Chicago, ASC leaders, surgeons and healthcare executives will explore strategies to drive growth, enhance operational performance, navigate reimbursement challenges and prepare for the future of ambulatory surgery. Apply for complimentary registration now.