The University of Iowa Pharmaceuticals Passed Pre-Approval Inspection for Aseptically Filled Sterile Drug Product

IOWA CITY, Iowa--(BUSINESS WIRE)--In September 2009, the Kansas City District Office of the Food and Drug Administration (FDA) submitted a recommendation of approval to the Center for Drug Evaluation and Research for The University of Iowa Pharmaceuticals (UIP) to manufacture and test an aseptically filled, sterile prescription drug product for a commercial client. The drug product contains a new chemical entity and is a sterile solution that is aseptically filled into vials.

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