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.

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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.

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