As previously announced, POZEN Inc., a Delaware corporation (“POZEN”), requested a Type A meeting with the United States Food and Drug Administration (“FDA”) FDA to discuss the next steps required to gain approval of its New Drug Application (“NDA”) for its investigational drug candidates YOSPRALA™ 81/40 and 325/40 (aspirin / omeprazole delayed release tablets) after receiving a second complete response letter (CRL) on December 16, 2014 from the FDA stating that during an inspection of the foreign manufacturing facility of an active ingredient supplier on April 25, 2014, a FDA field investigator conveyed deficiencies to the representative of the facility.  Satisfactory resolution of these deficiencies is required before this application may be approved.

 

FDA granted the Type A meeting, which was held in late January 2015 and included representatives from POZEN and its active ingredient supplier, the FDA’s Office of Compliance and the reviewing division.  At the meeting, representatives from the Office of Compliance stated that the active ingredient supplier’s responses to the 483 inspectional observations submitted in May 2014 were still under review and the Office of Compliance would be communicating with the supplier in the coming weeks.

 

POZEN has provided and will continue to provide assistance to its active ingredient supplier in taking corrective actions to address the inspectional observations at its facility.