New Drug Application for Yosprala Resubmitted
Aralez Pharmaceuticals Inc resubmitted its new drug application to the FDA for its investigational candidate PA32540/PA8140 as secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
Aralez Pharmaceuticals Inc resubmitted its new drug application to the FDA for its investigational candidate PA32540/PA8140 (Yosprala) as secondary prevention of cardiovascular disease in patients at risk for aspirin-induced gastric ulcers.
The application is being resubmitted following the FDA’s complete response letter to the first application. The FDA identified deficiencies after an audit of the manufacturing facility of the active pharmaceutical ingredient (API) aspirin supplier.
In response, Aralez’s application includes a new primary aspirin API supplier, with an alternative supplier “intended to address the deficiencies the FDA outlined in the complete response letter.”
The final agreement on the draft product labeling is pending, according to Aralez.
"We are pleased to resubmit the new drug application package for Yosprala," said Adrian Adams, CEO of Aralez, in a press release. "… We believe that, if approved, Yosprala has the potential to help millions of adults at risk for aspirin-induced ulcers.”
Aralez expects the FDA to acknowledge the resubmission of its new drug application within the next 30 days. If accepted, the FDA will provide a new prescription drug user fee act date.