SCHAUMBURG, Ill. In response to Baxter International’s decision to stop selling its blood thinning heparin drug earlier this month due to production difficulties, APP Pharmaceuticals has said it is prepared to meet demands for multi-dose vials of heparin. Baxter had supplied approximately half of the heparin in the U.S. but had to suspend production of its multi-dose vials after recalling lots of the drug due to a spike in serious adverse events.
APP recently received approval from the Food and Drug Administration for additional heparin manufacturing lines and has instituted a direct delivery program to control the distribution and expedite delivery of the drug.
The highly publicized recall and production stoppage intensified congressional scrutiny of the FDA’s foreign inspections program after reports recently surfaced that the agency never inspected a Chinese facility that produced the active pharmaceutical ingredient for Baxter’s drug.