FDA gives complete response for PA 32540/PA 8140 for Gastric Ulcers - Pozen

Pozen has received a complete response letter (CRL) from the FDA for PA 8140/PA 32540 (aspirin and omeprazole) delayed release tablets for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced Gastric Ulcers. The FDA noted that, during an inspection of the manufacturing facility of an active ingredient supplier, deficiencies were found. Satisfactory resolution of deficiencies noted by the field investigator is required before the NDA may be approved.

Pozen believes that these manufacturing facility items can be addressed and will be working with the manufacturer to respond to the FDA as soon as possible. There were no clinical or safety deficiencies noted with respect to either PA 8140 or PA 32540 and no other deficiencies were noted in the CRL. Final agreement on the draft product labeling is also pending.