Pozen takes aspirin/omeprazole combo back to FDA
- Pozen is resubmitting its application for PA8140/PA32540 (aspirin/omeprazole) to FDA and will receive a new PDUFA agreement date within 14 days.
- The resubmission is necessary due to FDA concerns about a manufacturing facility that produces an active pharmaceutical ingredient (API) to manufacture their product.
- Pozen conducted an onsite audit to ensure that everything is in order.
Pozen’s first candidate, a formulation of 81 mg of aspirin combined with 40 mg of immediate-release omeprazole, got a setback when Pozen received a complete response letter in late April citing deficiencies in the company’s API supplier’s manufacturing facility. The company has quickly addressed that issue and is awaiting a new PDUFA data.
PA8140/PA32540 is being developed as a once-daily medication for secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
- First Word Pharma POZEN Resubmits PA8140/PA32540 NDA