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  1. Development & Approval Process (CBER)

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.

2021 Biological License Application Supplement Noteworthy Approvals
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
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