2021 Biological License Application Supplement Noteworthy Approvals
This list reflects information regarding the supplements as of the approval date. It is not updated with regard to applicant or application status changes. The supplements are listed by date of approval, with the most recent action at the top.
| Tradename/Proper Name | Indication for Use | STN | Manufacturer/ License No. |
Approval Date |
|---|---|---|---|---|
| KOVALTRY Antihemophilic Factor (Recombinant), Full Length |
To provide the Clinical Study Report (CSR) for Postmarketing Commitment #1 noted in the approval letter for STN BL 125574/0 and to update Section 6 of the Prescribing Information to include information related to inhibitor development in previously untreated patients with hemophilia A. | 125574/400 | Bayer HealthCare LLC 100 Bayer Boulevard P.O. Box 915 Whippany, NJ 07981-0915 Lic. # 0008 |
01/08/2021 |