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  1. Development & Approval Process (CBER)

2020 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 in reverse chronological order.

2020 Biological License Application Approvals
Tradename/Proper Name Indication for Use STN Manufacturer/
License Number
Approval Date
AUDENZ
Influenza A (H5N1) Monovalent Vaccine, Adjuvanted
Indicated for active immunization for the prevention of disease caused by the influenza A virus H5N1 subtype contained in the vaccine. 125692/0 Seqirus Inc.
50 Hampshire Street
9th Floor
Cambridge, MA 02139

Lic. # 2049
01/31/2020
PALFORZIA
Peanut (Arachis hypogaea) Allergen Powder
Indicated for the mitigation of allergic reactions, including anaphylaxis, that may occur with accidental exposure to peanut. 125696/0 Aimmune Therapeutics, Inc.
8000 Marina Boulevard
Brisbane, CA 94005-1884

Lic. # 2109
01/31/2020