API Suppliers
US DMFs Filed
CEP/COS Certifications
0
JDMFs Filed
Other Certificates
0
Other Suppliers
0
0
USA (Orange Book)
Europe
0
Canada
0
Australia
0
South Africa
0
Uploaded Dossiers
0
U.S. Medicaid
0
Annual Reports
0
0
Details:
The approval is based on results of a Phase III clinical study (CONSOLE6) comparing the efficacy and safety of Arokaris® versus fosaprepitant in patients receiving highly emetogenic chemotherapy in combination with palonosetron and dexamethasone.
Lead Product(s): Fosnetupitant Chloride
Therapeutic Area: Gastroenterology Product Name: Arokaris
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 28, 2022
Details:
Taiho Pharmaceutical has submitted to the Japanese Ministry of Health, Labour and Welfare a new drug application for an NK1 receptor antagonist antiemetic drug for gastrointestinal symptoms (nausea and vomiting) associated with cancer chemotherapy.
Lead Product(s): Fosnetupitant Chloride
Therapeutic Area: Gastroenterology Product Name: Pro-NETU
Highest Development Status: Phase IIIProduct Type: Small molecule
Partner/Sponsor/Collaborator: Not Applicable
Deal Size: Not Applicable Upfront Cash: Not Applicable
Deal Type: Not Applicable March 23, 2021
Details:
Berlin-Chemie AG has been granted exclusive rights to import, distribute, promote, market and sell AKYNZEO® and ONICIT® in Russia and CIS region to manage chemotherapy-induced nausea and vomiting.
Lead Product(s): Fosnetupitant Chloride,Palonosetron
Therapeutic Area: Gastroenterology Product Name: Undisclosed
Highest Development Status: ApprovedProduct Type: Small molecule
Partner/Sponsor/Collaborator: Helsinn Group
Deal Size: Undisclosed Upfront Cash: Undisclosed
Deal Type: Licensing Agreement January 27, 2020