Health care investor Water Street Healthcare Partners reported on Monday the receipt of approval from the US Food and Drug Administration (FDA) for cardiovascular medication Bivalirudin in 0.9% Sodium Chloride Injection (bivalirudin) following its strategic partnership with a medical products company.
The US FDA approval of bivalirudin marks the fifth drug product successfully developed by Water Street's company, Celerity Pharmaceuticals LLC.
The company said bivalirudin is the first presentation in a frozen, premixed, ready-to-use formulation.
In conjunction, Celerity both funded and led the development and approval of bivalirudin through its strategic partnership with the medical products company.
Upon the US FDA approval of bivalirudin, Celerity transferred ownership to its partner, which will commercially launch the new product in the US.
GSK wins European Commission approval for Shingrix prefilled syringe
Tri-City Cardiology adds new members to care team
GENinCode expands Mexico presence with CARDIO inCode-Score distribution agreement
Cereno Scientific's Phase IIb trial of CS1 in PAH approved by US FDA
InsiteOne agrees strategic partnerships with ASCEND Cardiovascular and Apollo Enterprise Imaging
Gan & Lee Pharmaceuticals launches third phase 3 trial of once-monthly bofanglutide
Remington Medical's VascuChek 2.0 Cordless Bluetooth-Enabled Doppler Secures FDA Clearance
LivaNova secures higher Medicare reimbursement for VNS Therapy procedures