ACAM2000
Smallpox and Mpox (Vaccinia) Vaccine, Live 
8/29/2024 
Package Insert
Clinical Review
Statistical Review 
ADACEL
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed 
1/9/2023 
Package Insert
Clinical Review
Statistical Review 
Advate
Antihemophilic Factor (Recombinant), Plasma/Albumin Free Method 
12/14/2011 
Package Insert
Clinical Review
Statistical Review and Evaluation 
ADYNOVATE
Antihemophilic Factor (Recombinant), PEGylated 
12/22/2016 
Package Insert
Statistical Review
Clinical Review 
11/13/2015 
Package Insert
Statistical Review
Clinical Review 
Afluria
Influenza Virus Vaccine 
10/4/2018 
Package Insert 
11/10/2009 
Package Insert
Statistical Review and Evaluation
Clinical Review 
AFLURIA QUADRIVALENT
Influenza Vaccine 
10/4/2018 
Package Insert
Clinical Review
Statistical Review
Statistical Review Addendum 
8/31/2017 
Package Insert
Clinical Review
Statistical Review 
AFSTYLA
Antihemophilic Factor (Recombinant), Single Chain 
5/25/2016 
Package Insert
Statistical Review
Clinical Review 
Agriflu
Influenza Virus Vaccine 
1/28/2020 
Package Insert
Clinical Review
Statistical Review 
Artiss
Fibrin Sealant (Human) 
3/19/2008 
Package Insert
Statistical Review and Evaluation
Clinical Review 
ASCENIV
Immune Globulin Intravenous, Humanslra, 10% Liquid 
4/1/2019 
Package Insert
Statistical Review
Clinical Review 
AUDENZ
Influenza A (H5N1) Monovalent Vaccine, Adjuvanted 
1/31/2020 
Package Insert
Clinical Review
Statistical Review 
BEXSERO
Meningococcal Group B Vaccine 
1/23/2015 
Package Insert
Statistical Review
Clinical Review 
BIVIGAM
Immune Globulin Intravenous (Human), 10% 
12/8/2023 
Package Insert
Clinical Review
Statistical Review 
BOOSTRIX
Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed 
10/7/2022 
Package Insert
Clinical Review
Statistical Review 
Cervarix
Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant 
7/14/2011 
Statistical Review and Evaluation
Clinical Review 
10/16/2009 
Package Insert
Statistical Review and Evaluation
Clinical Review Memo 
COMIRNATY
COVID19 Vaccine, mRNA 
9/11/2023 
Package Insert
Clinical Review
Statistical Review 
7/8/2022 
Package Insert
Clinical Review
Statistical Review 
8/23/2021 
Package Insert
Clinical Review
Statistical Review
Statistical Review
Statistical Review 
CUTAQUIG
Immune Globulin Subcutaneous (Human) hipp, 16.5% 
10/22/2021 
Package Insert
Clinical Review
Statistical Review 
CUVITRU
Immune Globulin Subcutaneous (Human), 20% Solution 
9/13/2016 
Package Insert
Clinical Review
Statistical Review 
Daptacel
Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed 
3/12/2008 
Package Insert
Clinical Review 
DENGVAXIA
DENGUE Tetravalent Vaccine, Live 
6/30/2023 
Package Insert
Clinical Review
Statistical Review 
5/1/2019 
Package Insert
Clinical Review
Statistical Review 
ERVEBO
Ebola Zaire Vaccine, Live 
7/27/2023 
Package Insert
Clinical Review
Statistical Review 
ESPEROCT
Antihemophilic Factor (Recombinant), GlycoPEGylatedexei 
2/19/2019 
Package Insert
Clinical Review
Statistical Review 
Evicel
Fibrin Sealant (Human) 
1/2/2008 
Package Insert
Clinical Efficacy Supplement Final Review Memo
Statistical Review and Evaluation 
FIBRYGA
Fibrinogen (Human) 
7/31/2024 
Package Insert
Clinical Review
Statistical Review 
12/23/2020 
Package Insert
Clinical Review
Statistical Review
Clinical Pharmacology Supplemental Review 
6/7/2017 
Package Insert
Clinical Review
Statistical Review 
FLUAD
Influenza Vaccine, Adjuvanted 
10/28/2020 
Package Insert
Clinical Review
Statistical Review 
FLUAD QUADRIVALENT
Influenza Vaccine, Adjuvanted 
12/4/2020 
Package Insert 
10/28/2020 
Clinical Review
Statistical Review 
Fluarix
Influenza Virus Vaccine 
10/19/2009 
Package Insert
Statistical Review and Evaluation
Clinical Review 
Fluarix Quadrivalent
Influenza Virus Vaccine 
1/11/2018 
Package Insert
Clinical Review
Statistical Review 
12/14/2012 
Package Insert
Clinical Review
Statistical Review and Evaluation 
Flucelvax
Influenza Vaccine 
5/23/2016 
Package Insert
Statistical Review
Clinical Review Addendum 
Flucelvax Quadrivalent
Influenza Vaccine 
10/14/2021 
Package Insert
Clinical Review
Statistical Review 
3/3/2021 
Package Insert
Clinical Review
Statistical Review 
5/23/2016 
Package Insert
Clinical Review
Statistical Review Addendum
Statistical Review 
FluLaval
Influenza Virus Vaccine 
11/18/2016 
Package Insert
Clinical Review
Statistical Review and Evaluation
Statistical Review Assay 
8/16/2013 
Package Insert
Clinical Review
Statistical Review and Evaluation 
FluLaval Quadrivalent
Influenza Virus Vaccine 
11/18/2016 
Package Insert
Clinical Review
Statistical Review and Evaluation
Statistical Review Assay 
8/15/2013 
Package Insert
Statistical Review and Evaluation
Final Clinical Review 
FluMist Quadrivalent
Influenza Vaccine Live, Intranasal 
2/29/2012 
Package Insert
Clinical Review
Statistical Review and Evaluation 
Fluzone HighDose Quadrivalent
Influenza Virus Vaccine 
1/23/2019 
Package Insert
Clinical Review
Statistical Review 
6/7/2013 
Package Insert
Clinical Review
Statistical Review and Evaluation 
Gammagard Liquid
Immune Globulin Infusion (Human) 
7/22/2011 
Package Insert
Clinical Review
Statistical Review and Evaluation 
Gammaplex
Immune Globulin Intravenous (Human) 5% Liquid 
7/30/2015 
Package Insert
Clinical Review
Statistical Review 
GamunexC
Immune Globulin Injection (Human), 10%, Caprylate/Chromatography Purified

12/4/2015 
Package Insert
Clinical Review
Clinical Pharmacology Review 
Gardasil
Human Papillomavirus Quadrivalent (Types 6, 11, 16, 18) Vaccine, Recombinant 
12/22/2010 
Package Insert
Clinical Review
Statistical Review and Evaluation 
10/16/2009 
Package Insert
Clinical Review
Statistical Review 
9/12/2008 
Package Insert
Clinical Review
Statistical Review and Evaluation 
Gardasil 9
Human Papillomavirus 9valent Vaccine, Recombinant 
6/12/2020 
Package Insert
Clinical Review 
10/7/2016 
Package Insert
Clinical Review
Statistical Review 
12/10/2014 
Package Insert
Clinical Review
Statistical Review 
Grastek
Timothy Grass Pollen Allergen Extract 
4/11/2014 
Package Insert
Clinical Review
Statistical Review 
Hemacord
Hematopoietic progenitor cells, cord blood 
11/10/2011 
Package Insert
Clinical and Statistical Joint Review 
Hiberix
Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate) 
1/14/2016 
Package Insert
Clinical Review
Statistical Review 
8/19/2009 
Package Insert
Clinical Review
Statistical Review 
Hizentra
Immune Globulin Subcutaneous (Human), 20% Liquid 
9/25/2013 
Package Insert 
10/3/2011 
Package Insert
Statistical Review and Evaluation
Clinical Review 
2/17/2011 
Package Insert
Clinical Review 
HYQVIA
Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase 
4/7/2023 
Package Insert
Clinical Review
Statistical Review 
Ixiaro
Japanese Encephalitis Vaccine, Inactivated, Adsorbed 
4/13/2018 
Package Insert
Clinical Review
Statistical Review 
5/17/2013 
Package Insert
Clinical Review
Statistical Review and Evaluation 
IXINITY
Coagulation Factor IX (Recombinant) 
3/22/2024 
Package Insert
Statistical Review
Clinical Review
Clinical Pharmacology Review 
11/17/2022 
Package Insert
Clinical Review
Statistical Review 
4/29/2015 
Package Insert
Clinical Review 1
Clinical Review 2
Clinical Review 3
Statistical Review and Evaluation 
JIVI
Antihemophilic Factor (Recombinant), PEGylatedaucl 
8/29/2018 
Package Insert
Clinical Review
Statistical Review 
Kedbumin
Albumin (Human) 25% 
6/3/2011 
Package Insert
Clinical Review
Statistical Review and Evaluation 
KEDRAB
Rabies Immune Globulin (Human) 
5/17/2021 
Package Insert
Clinical Review
Preclinical PharmTox Review
Statistical Review 
Kogenate FS
Antihemophilic Factor (Recombinant) 
10/10/2008 
Package Insert
Clinical Review 
KINRIX
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine 
6/24/2008 
Package Insert
Clinical Review
Statistical Review 
KOVALTRY
Antihemophilic Factor (Recombinant) 
3/16/2016 
Package Insert (Vial Adapter)
Package Insert (BIOSET)
Clinical Review
Statistical Review 
Menactra
Meningococcal Polysaccharide (Serogroups A, C, Y and W135) Diphtheria Toxoid Conjugate Vaccine 
4/22/2011 
Package Insert
Clinical Review
Statistical Review
Pharmacovigilance Plan Review 
MenHibrix
Meningococcal Groups C and Y and Haemophilus b Tetanus Toxoid Conjugate Vaccine 
6/14/2012 
Package Insert
Statistical Review and Evaluation
Clinical Review 
MenQuadfi
Meningococcal (Groups A, C, Y, W) Conjugate Vaccine 
4/23/2020 
Package Insert
Clinical Review
Statistical Review 
Menveo
Meningococcal (Groups A, C, Y, and W135) Oligosaccharide Diphtheria CRM197 Conjugate Vaccine 
8/1/2013 
Package Insert
Clinical Review
Statistical Review 
1/28/2011 
Package Insert
Clinical Review
Statistical Review 
2/19/2010 
Package Insert
Clinical Review
Statistical Review 
MMR II
Measles, Mumps and Rubella Virus Vaccine Live 
2/27/2023 
Package Insert
Clinical Review
Statistical Review 
Novoeight
Antihemophilic Factor (Recombinant) 
10/15/2013 
Package Insert
Clinical Review
Statistical Review and Evaluation 
NUWIQ
Antihemophilic Factor (Recombinant) 
9/4/2015 
Package Insert
Clinical Review
Statistical Review 
Octaplas
Pooled Plasma (Human), Solvent/Detergent Treated 
2/25/2021 
Package Insert
Clinical Memo 
3/29/2019 
Package Insert
Clinical Review 
ODACTRA
House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract 
1/20/2023 
Package Insert
Clinical Review
Statistical Review 
ORALAIR
Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract 
11/9/2018 
Package Insert & Medication Guide
Statistical Review
Clinical Review 
4/1/2014 
Package Insert
Statistical Review
Clinical Review 
PALFORZIA
Peanut (Arachis hypogaea) Allergen Powderdnfp 
7/26/2024 
Package Insert
Clinical Review
Statistical Review 
1/31/2020 
Package Insert
Clinical Review
Statistical Review 
PANZYGA
Immune Globulin Intravenous, humanifas 
8/2/2018 
Package Insert
Clinical Review
Statistical Review 
PENBRAYA
Meningococcal Groups A, B, C, W, and Y Vaccine 
10/20/2023 
Package Insert
Clinical Review
Statistical Review 
Pentacel
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus and Haemophilus b Conjugate (Tetanus Toxoid Conjugate) Vaccine 
6/20/2008 
Package Insert
Clinical Review
Statistical Review
Recommendations regarding request for partial waiver of pediatric studies 
Prevnar 13
Pneumococcal 13valent Conjugate Vaccine (Diphtheria CRM_{197} Protein) 
1/25/2013 
Package Insert
Clinical Review
Statistical Review and Evaluation 
2/24/2010 
Package Insert
Clinical Review
Statistical Review and Evaluation 
PREVNAR 20
Pneumococcal 20valent Conjugate Vaccine 
4/27/2023 
Package Insert
Clinical Review
Statistical Review 
PRIORIX
Measles, Mumps and Rubella Vaccine, Live 
6/3/2022 
Package Insert
Clinical Review
Statistical Review 
PROQUAD
Measles, Mumps, Rubella and Varicella Virus Vaccine Live 
2/27/2023 
Package Insert (Frozen)
Package Insert (Refrigerated)
Clinical Review
Statistical Review 
QPan
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted 
9/9/2016 
Package Insert
Clinical Review
StatisticalClinical Review
StatisticalClinical Review  Addendum 
Quadracel
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine 
3/24/2015 
Package Insert
Clinical Serology and Bioassay Review, and Approval Memo
Clinical Statistical Review 
RAGWITEK
Short Ragweed Pollen Allergen Extract (Ambrosia artemisiifolia) 
4/16/2021 
Package Insert
Clinical Review
Statistical Review 
REBINYN
Coagulation Factor IX (Recombinant), GlycoPEGylated 
5/31/2017 
Package Insert
Clinical Review
Statistical Review 
RECOTHROM
Thrombin, topical (Recombinant) 
3/15/2013 
Package Insert
Clinical Review
Final Clinical Labeling Memo 
Rixubis
Coagulation Factor IX (Recombinant) 
9/12/2014 
Package Insert
Clinical Review
Statistical Review 
Rotarix
Rotavirus Vaccine, Live, Oral 
4/3/2008 
Package Insert
Clinical Review
Statistical Review and Evaluation 
RotaTeq
Rotavirus Vaccine, Live, Oral, Pentavalent 
2/23/2017 
Package Insert
Clinical Review
Statistical Review 
Rubber Panel T.R.U.E. TEST
Rubber Panel ThinLayer Rapid Use Epicutaneous Patch Test 
3/3/2017 
Package Insert
Clinical Review
Statistical Review 
SEVENFACT
coagulation factor VIIa (recombinant)jncw 
11/22/2022 
Package Insert
Clinical Review 
4/1/2020 
Package Insert
Clinical Review
Statistical Review 
SPIKEVAX
COVID19 Vaccine, mRNA 
9/11/2023 
Package Insert
Clinical Review
Statistical Review 
TachoSil
TACHOSIL® Fibrin Sealant Patch 
7/15/2015 
Package Insert
Clinical Review
Statistical Review 
TICOVAC
TickBorne Encephalitis Vaccine 
8/13/2021 
Package Insert
Clinical Review
Statistical Review 
TISSEEL
Fibrin Sealant 
1/25/2012 
Package Insert
Clinical Review
Statistical Review and Evaluation 
T.R.U.E. TEST
ThinLayer Rapid Use Epicutaneous Patch Test 
8/25/2017 
Package Insert
Clinical Review
Statistical Review 
TRUMENBA
Meningococcal Group B Vaccine 
4/14/2016 
Package Insert
Clinical Review
Statistical Review
Addendum to Statistical Review 
10/29/2014 
Package Insert
Clinical Review
Statistical Review 
VARIVAX
Varicella Virus Vaccine Live 
2/27/2023 
Package Insert (Frozen)
Package Insert (Refrigerated)
Clinical Review
Statistical Review 
VAXCHORA
Cholera Vaccine, Live, Oral 
12/23/2020 
Package Insert
Clinical Review
Statistical Review 
VAXELIS
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed, Inactivated Poliovirus, Haemophilus b Conjugate [Meningococcal Protein Conjugate] and Hepatitis B [Recombinant] Vaccine 
12/21/2018 
Package Insert
Clinical Review
Statistical Review 
VAXNEUVANCE
Pneumococcal 15valent Conjugate Vaccine 
6/17/2022 
Package Insert
Clinical Review
Statistical Review 
VISTASEAL
FIBRIN SEALANT (Human) 
9/27/2024 
Package Insert 
Voluven
6% Hydroxyethyl Starch 130/0.4 in 0.9% Sodium Chloride Injection 
5/17/2012 
Package Insert
Clinical Review (BN070012/145)
Statistical Review and Evaluation (BN070012/145) 
12/27/2008 
Package Insert
Clinical PREA Review Memo
Clinical Pharmacology 
Wilate
von Willebrand Factor/Coagulation Factor VIII Complex (Human) 
3/22/2024 
Package Insert
Clinical Review 
12/1/2023 
Package Insert
Clinical Pharmacology Review
Clinical Review
Statistical Review 
9/25/2019 
Package Insert
Clinical Review
Statistical Review 
8/5/2015 
Package Insert
Clinical Review
Statstical Review 
XEMBIFY
Immune Globulin Subcutaneous, Human  klhw, 20% 
7/18/2024 
Package Insert
Clinical and Clinical Pharmacology Review
Statistical Review 
7/3/2019 
Package Insert
Clinical Review
Statistical Review 
XYNTHA
Antihemophilic Factor (Recombinant), Plasma/Albumin Free 
8/13/2020 
Package Insert
Package Insert
Clinical Review
Statistical Review 
YIMMUGO
immune globulin intravenous, humandira 
6/13/2024 
Package Insert
Clinical Review
Statistical Review 