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  4. 2025 Biological License Application Supplement Noteworthy Approvals
  1. Development & Approval Process (CBER)

2025 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.

2025 Biological License Application Supplement Noteworthy Approvals
Tradename/Proper NameIndication for UseSTNManufacturer/
License No.		Approval Date
ODACTRA
House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract		To include use in children 5 through 11 years of age.125592/218ALK-Abello A/S
ALK-Abello Inc.
135 Route 202/206 Suite 16
Bedminster, NJ 07921

Lic. #1292		02/27/2025
Anti-Human GlobulinTo replace the Anti-C3d used in MTS Anti-IgG, -C3d gel cards manufactured in Pompano Beach, Florida facility.103461/5123Micro Typing Systems, Inc.
100 Indigo Creek Drive
Rochester, NY 14626

Lic. #1177		01/28/2025
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