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.
|Tradename/Proper Name||Indication for Use||STN||Manufacturer/
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
Cambridge, MA 02139
Lic. # 2049
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