2023 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 |
|---|---|---|---|---|
| DENGVAXIA Dengue Tetravalent Vaccine, Live |
To include data on the immune response to Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine Adsorbed (Adacel) when administered concomitantly with DENGVAXIA | 125682/37 | Sanofi Pasteur Inc. Discovery Drive Swiftwater, PA 18370-0187 Lic. # 1725 |
01/25/2023 |
| ODACTRA House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract |
To include use in adolescents 12 through 17 years of age | 125592/157 | ALK-Abello A/S 135 Route 135 202/206 Bedminster, NJ 20879 Lic. # 1292 |
01/20/2023 |
| ADACEL Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed |
To include immunization during the third trimester of pregnancy to prevent pertussis in infants younger than 2 months of age. | 125111/904 | Sanofi Pasteur Limited 1755 Steele Avenue Toronto, Ontario Canada M2R 3T4 Lic. # 1726 |
01/09/2023 |