Water Street’s Partnership Program Achieves Another FDA Approval
Water Street announced today that its development partnership with a leading medical products company has resulted in the U.S. Food and Drug Administration (FDA) approval of cardiovascular medication Bivalirudin in 0.9 percent Sodium Chloride Injection (bivalirudin). It is the first presentation of bivalirudin in a frozen, premixed, ready-to-use formulation.
The approval of bivalirudin marks the fifth drug product successfully developed by Water Street’s company, Celerity Pharmaceuticals, LLC. Celerity both funded and led the development and approval of bivalirudin through its strategic partnership with the medical products company. Following FDA approval of bivalirudin, Celerity transferred ownership to its partner, which will commercially launch the new product in the United States.
“We are honored that our partner entrusted us to develop this new presentation of bivalirudin – the first in the United States and the only available in a frozen premixed solution,” said Al Heller, operating partner with Water Street and chairman of Celerity. “We look forward to continuing to work together to advance our partner’s goal of engaging its innovative technologies with medicines that help simplify drug preparation and help bolster clinician efficiency.”