Pozen’s Yosprala Receives Complete Response Letter from the FDA

Pozen Inc. has announced that their investigational drug candidates Yosprala 81/40 and 325/40 (aspirin/omeprazole delayed release tablets) have received a second complete response letter (CRL) from the FDA. 

In this CRL, the FDA used identical wording to that of the first CRL, which was that during an inspection of the foreign manufacturing facility of an active ingredient supplier on 25 April 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. There were no clinical or safety deficiencies noted with respect to either Yosprala 81/40 or Yosprala 325/40 and no other deficiencies were noted in the CRL. Final agreement on the draft product labeling is also pending.

The supplier responded to FDA’s deficiencies in May 2014 with a complete plan of action to correct all of the deficiencies noted. Since that time, the supplier has provided updates to the FDA on their progress on the action plan. During interactions today (17 December 2014) with the supplier, Pozen confirmed that there has been no new inspection of the facility from the compliance division at the FDA since last April, and that the facility has received no communication or comment from the compliance division at the FDA with respect to the supplier’s action plan and progress on the plan to address the deficiencies, other than informing the supplier that the matter is under review and that the division has many competing priorities.

“Based on inspections at the site by an expert consultant we retained and our review of all relevant documents and communications with the supplier’s personnel, we believe that the FDA issues raised during the April inspection have been adequately addressed. So, our goal continues to be to do everything we can to assist the FDA compliance division with their review and to encourage them to move to completion of their review as soon as possible since this remains the only outstanding issue,” said John R. Plachetka, Chairman, President and CEO. “FDA regulations allow us to request a Type A meeting with the FDA to discuss the next steps required to gain approval of our NDA and we intend to request that meeting as soon as possible.”