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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
Gardasil 9
Human Papillomavirus 9-valent Vaccine, Recombinant
To update the Adverse Reactions and Clinical Studies sections of the package insert to include data from Clinical Trial V503-004, “An Open-Label Phase III Clinical Trial to Study the Immunogenicity and Tolerability of GARDASIL®9 (A Multivalent Human Papillomavirus [HPV] L1 Virus-Like Particle [VLP] Vaccine) in Adult Women (27 to 45 Year-Olds) compared to Young Adult Women (16 to 26 Year-Olds).” 125508/787 Merck Sharp & Dohme Corp.
351 N. Sumneytown Pike
P.O. Box 1000
UG2D-68
North Wales, PA 19454

Lic. #0002
08/20/2020
XYNTHA SOLOFUSE; XYNTHA
Antihemophilic Factor (Recombinant), Plasma/Albumin Free
To include a new indication of routine prophylaxis to reduce the frequency of bleeding episodes in children and adults with hemophilia A. 125264/1670 Wyeth Pharmaceuticals, LLC
235 E. 42nd St 219/9/1
New York, NY 10017

Lic. #0003
08/13/2020
BeneFIX
BeneFIX RTS

Coagulation Factor IX (Recombinant)
New Indication: for routine prophylaxis to prevent or reduce the frequency of bleeding episodes in patients with hemophilia B (congenital factor IX deficiency or Christmas disease) 103677/6512 Wyeth Pharmaceuticals LLC
235 East 42nd Street
New York, NY 10017-7555

Lic. #0003
06/26/2020
Gardasil 9
Human Papillomavirus 9-valent Vaccine, Recombinant
To expand the indication to include the prevention of oropharyngeal and other head and neck cancers caused by HPV. 125508/868 Merck Sharp & Dohme Corp.
351 N. Sumneytown Pike
P.O. Box 1000
UG2D-68
North Wales, PA 19454-2505

Lic. #0002
06/12/2020
Blood Grouping Reagent, Anti-e (Monoclonal)(Formulated for Automated Testing) To include additional Anti-e FFMU cell lines MS16 and MS21, from Millipore located in Loss, France, for Further Manufacturing Use (FFMU) in vitro substances and to validate its use on the Beckman Coulter Automated System PK7400. 125176/38 125176/38 DIAGAST
NAMSA
400 Highway 169 South, Suite 500
Minneapolis, MN 55426

Lic. #1744
05/07/2020
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

 

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