In this latest CRL for two forms of Yosprala (aspirin/omeprazole delayed release tablets), the FDA used identical wording to that of the first CRL, which said that during an inspection of the foreign manufacturing facility of an active ingredient supplier in April, 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. Pozen stock fell about 10% on Wednesday following the release of the news
John Plachetka, Chairman, President and CEO, expressed frustration in the conference call on the CRL on Wednesday, noting that despite the Form 483 that stopped the approval of these treatments, the API supplier continues to produce “enormous amount of product sold in the US…and there has been no action to stop the import of those products.”
He said these and other questions will be addressed in an upcoming meeting with the FDA.
The supplier responded to FDA’s deficiencies in May, 2014 with a complete plan of action to correct all of the deficiencies noted. Since then, the supplier has provided updates to the FDA on their progress on the action plan, Pozen says.
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.
Plachetka also noted that to switch manufacturers at this point would “incur a substantial time investment… the solution that we believe is achievable is to get the [FDA] compliance division to evaluate the progress made in this facility, but it’s our belief after being on site with qualified third-party inspectors that they’ve responded to observations to the April 483.”
“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 Plachetka.
He added in the call that the treatments will not be approved until Q2 2015 at the earliest, “though Q3 is more likely.”
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 company said.