2009 Biological License Application Approvals
This list reflects information regarding the applications as of the approval date. It is not updated with regard to applicant or application status changes. The applications are listed by date of approval.
- Complete List of Currently Licensed Products and Establishments
- Transfer of Therapeutic Products to CDER
Note: Approvals are listed with the most recent action at the top.
Tradename/ Proper Name |
Indication for Use | STN | Manufacturer/ License Number |
Approval Date |
---|---|---|---|---|
RiaSTAP Fibrinogen Concentrate (Human) |
For the treatment of acute bleeding episodes in patients with congenital fibrinogen deficiency (afibrinogenemia and hypofibrinogenemia). | 125317/0 | CSL Behring GmbH | 1/16/2009 |