Pozen Inc, a pharmaceutical company committed to transforming medicine that transforms lives, announced today 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 U.S. Food and Drug Administration (FDA). A CRL is issued by the FDA when the review of the file is completed and questions remain that preclude the approval of the new drug application (NDA) in its current form.

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 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. 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 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.

For more details, go to: http://investors.pozen.com/phoenix.zhtml?c=121701&p=IROL-NRText&t=NewsRelease&id=2000038&highlight=