Pozen announced that the FDA has issued a second Complete Response Letter (CRL) in response to the New Drug Application (NDA) for Yosprala (aspirin and omeprazole delayed-release tablets) 81/40 and 325/40.

In the CRL, the FDA noted similar deficiencies to those stated on the first CRL. Satisfactory resolution of these deficiencies is required before the NDA can be approved. There were no clinical or safety deficiencies noted with respect to either Yosprala 81/40 or 325/40. Final agreement on the draft product labeling is also pending.

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. Yosprala 325/40 contains 325mg of aspirin while Yosprala 81/40 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.