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 |
|---|---|---|---|---|
| IXIARO Japanese Encephalitis Vaccine, Inactivated, Adsorbed |
Active immunization against Japanese Encephalitis Virus | 125280/0 |
Intercell AG |
3/30/2009 |
| ATryn Antithrombin (Recombinant) |
For the prevention of peri-operative and peri-partum thromboembolic events, in hereditary antithrombin deficient patients. | 125284/0 | GTC Biotherapeutics, Inc. 175 Crossing Blvd. Framingham , MA 01702 License 1794 |
2/6/2009 |
| 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 |