POZEN announced that the FDA has issued a Complete Response Letter (CRL) for its 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.
The FDA cited inspection deficiencies found upon evaluation of the active ingredient supplier’s manufacturing facility; however, they did not note any clinical or safety deficiencies with respect to either PA8140 or PA32540. Pozen believes the manufacturing facility items can be addressed and will work in conjunction with its manufacturer to respond to the FDA as quickly as possible.
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.