Third party ingredient supplier issues delay FDA approval for Pozen NDA

US drugmaker Pozen (Nasdaq: POZN) says that its drug candidates PA8140/PA32540 (aspirin and omeprazole) delayed release tablets have received a complete response letter (CRL) from the US Food and Drug Administration, meaning that questions remain which preclude the approval of the New Drug Application in its current form.

In the CRL, the FDA noted that, during an inspection of the manufacturing facility of an active ingredient supplier that concluded this week, inspection deficiencies were found. Satisfactory resolution of deficiencies noted by the field investigator is required before the NDA may be approved.

This novel, patented product is intended for oral administration once a day and an indication is being sought for use for the secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.