Water Street Partnership 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 and commercial launch of ready-to-use clindamycin injection in dextrose.
Water Street’s company, Celerity Pharmaceuticals, LLC, is funding and leading the development and approval of nine product families using its partner’s proprietary container technology, enhanced packaging platform, and aseptic filling manufacturing process. Following FDA approval of this new product, Celerity transferred ownership of the ANDA to its partner, which recently commercially launched the product in the United States. The approval of clindamycin in dextrose is the fourth drug product developed and approved as part of this joint effort.
“With this newest approval, we have again demonstrated our unique capabilities in developing and gaining FDA approval on medicines that are in high demand for use in hospitals across the country,” said Al Heller, operating partner with Water Street and chairman of Celerity. “We look forward to continuing to work together to advance our joint goals to develop additional medicines important for patient care.”