The U.S. Food and Drug Administration sent AstraZeneca a Complete Response Letter, rejecting a new drug application for the company's Axanum, according to an AstraZeneca news release.
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.