FDA Accepts NDA Resubmission for PA32540/PA8140
Pozen announced that the FDA has accepted for review its resubmission of a New Drug Application (NDA) for aspirin and omeprazole (PA32540/PA8140) delayed-release tablets.
Both products are coordinated-delivery tablet combinations of immediate-release omeprazole 40mg, a proton pump inhibitor, layered around a pH-sensitive coating of an aspirin core. PA32540 contains 325mg of aspirin while PA8140 contains 81mg of aspirin.
POZEN filed an NDA for the following proposed indications:
- To reduce the combined risk of death and nonfatal stroke in patients who have had ischemic stroke or transient ischemia of the brain due to fibrin platelet emboli
- To reduce the combined risk of death and nonfatal MI in patients with a previous MI or unstable angina pectoris
- To reduce the combined risk of MI and sudden death in patients with chronic stable angina pectoris
- In patients who have undergone revascularization procedures (CABG, PTCA) when there is a pre-existing condition for which aspirin is already indicated, and to decrease the risk of developing gastric ulcers in patients at risk for developing aspirin-associated gastric ulcers
For more information call (919) 913-1030 or visit Pozen.com.