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  1. Development & Approval Process (CBER)

2020 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.

2020 Biological License Application Supplement Noteworthy Approvals
Tradename/Proper Name Indication for Use STN Manufacturer/
License No.
Approval Date
Micrurus Fulvius
Antivenin (Micrurus fulvius)
Post Marketing Commitment to STN 101099/5105 for -(b)(4)---------------------------- on Lot H42803

Envenomation by Micrurus fulvius
101099/5109 Wyeth Pharmaceuticals, Inc.
Pfizer Essential Health, GRA Brands
235 East 42nd Street
New York, NY 10017

Lic. # 0003
03/27/2020
FLUAD QUADRIVALENT
Influenza Vaccine, Adjuvanted
For active immunization of persons 65 years of age and older against influenza disease caused by seasonal influenza virus subtypes A and types B contained in the vaccine 125510/143 Seqirus Inc.
50 Hampshire Street,
9th Floor
Cambridge, MA 02139

Lic. # 2049
02/21/2020
Nuwiq
Antihemophilic Factor (Recombinant), rAHF
To include wording changes in Product Information based on submission of new clinical data from study GENA-21 and study GENA-13 125555/137 Octapharma Pharmazeutika Produktionsges.m.b.H.
Octapharma USA Inc.
121 River Street, Suite 1201
Hoboken, NJ 07030

Lic. # 1646
01/29/2020
Agriflu
Influenza Virus Vaccine
To include data from three post-approval requirement/commitment studies conducted in pediatric and adult populations 125297/118 Seqirus Inc.
50 Hampshire Street,
9th Floor
Cambridge, MA 02139

Lic. # 2049
01/28/2020