Details:
U.S. FDA issued a CRL regarding the Company's NDA seeking approval for Teripress (terlipressin) to treat adults with hepatorenal syndrome, an acute and life-threatening syndrome and its safety and effectiveness have not yet been established by FDA.
Lead Product(s): Terlipressin Acetate
Therapeutic Area: Hepatology (Liver, Pancreatic, Gall Bladder) Product Name: Teripress
Highest Development Status: Phase III Product Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable February 22, 2022