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  1. Development & Approval Process (CBER)

2016 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.

2016 Biological License Application Supplement Noteworthy Approvals
Tradename/Proper Name Indication for Use STN Manufacturer/
License No.
Approval Date
Cinryze
C1 Esterase Inhibitor (Human)
To fulfill your postmarketing requirement as a condition of original approval to evaluate the safety of escalating doses of C1 Esterase Inhibitor (human) for routine prophylaxis of angioedema attacks in patients with Hereditary Angioedema (HAE) and to include labeling changes that reflect the results of the clinical trial, specifically updating sections pertaining to DOSAGE AND ADMINISTRATION, ADVERSE REACTIONS and CLINICAL TRIAL EXPERIENCE. 125267/723 ViroPharma Biologics, Inc.
300 Shire Way,
Lexington, MA, 02421

Lic. # 1833
12/23/2016
ADYNOVATE
Antihemophilic Factor (Recombinant), PEGylated
To expand clinical indication of ADYNOVATE to include on-demand treatment and control of bleeding episodes in children (< 12 years of age), routine prophylaxis to prevent or reduce the frequency of bleeding episodes in children (< 12 years of age), and perioperative management in adults and children. 125566/51 Baxalta US Inc.
One Baxter Way,
Westlake Village, CA, 91362

Lic. # 2020
12/22/2016
FLUARIX; FLUARIX Quadrivalent
Influenza Virus Vaccine
To include clinical data to support harmonization of the monovalent bulk manufacturing process at your Dresden manufacturing facility. 125127/775 GlaxoSmithKline Biologicals
Rue de l'Institut 89,
B1330 Rixensart

Lic. # 1617
11/18/2016
FluLaval; FluLaval Quadrivalent
Influenza Vaccine
To extend the age range of use of FluLaval® and FluLaval® Quadrivalent to include children 6 to 35 months of age. 125163/405 ID Biomedical Corporation of Quebec
2323 Technology Park Boulevard,
Quebec City, Quebec, Canada, G1P 4R8

Lic. # 1739
11/18/2016

IH-Card ABO/D (DVI-)+Rev A1, B; IH-Card ABO/D (DVI+)+Rev A1, B; IH-Card ABO/RhD(DVI+);
IH-Card Group ABO;
IH-Card ABD(DVI-)Conf;
IH-Card ABD(DVI+)-Conf


Blood Grouping Reagent, Anti-A (Murine Monoclonal)(Formulated for Automated Testing)

To include a new indication for your Blood Grouping Reagents (BGRs) as reactive components of a buffered-----(b)(4)----- gel suspension filled into the IH-Cards. The BGRs will be used for the detection and identification of blood grouping antigens based on the principles of hemagglutination and gel filtration. The IH-Cards are intended to be used on the IH-1000 Automated Analyzer System for ABO/RhD grouping and Rh/Kell Phenotyping. 125094/113

Bio-Rad Medical Diagnostics GmbH

Industriestrasse 1, D-63303 Dreieich
Germany

Lic. # 1845

10/20/2016

IH-Card ABO/RhD(DVI+);
IH-Card Group AB

Blood Grouping Reagent, Anti-A,B (Murine Monoclonal)(Formulated for Automated Testing)
To include a new indication for your Blood Grouping Reagents (BGRs) as reactive components of a buffered-----(b)(4)----- gel suspension filled into the IH-Cards. The BGRs will be used for the detection and identification of blood grouping antigens based on the principles of hemagglutination and gel filtration. The IH-Cards are intended to be used on the IH-1000 Automated Analyzer System for ABO/RhD grouping and Rh/Kell Phenotyping. 125096/58

Bio-Rad Medical Diagnostics GmbH

Industriestrasse 1, D-63303 Dreieich Germany

Lic. # 1845

10/20/2016

Anti-D-:
IH-Card ABO/D(DVI-)+Rev A1,B;
IH-Card ABD(DVI-)-Conf;
IH-Card Anti-D(DVI-);
IH-Card RhD(DVI-)+Phenotype
Anti-D+:
IH-Card ABO/D(DVI+)+Rev A1, B;
IH Card ABO/RhD(DVI+);
IH-Card ABD (DVI+)-Conf;
IH-Card Anti-D(DVI+)

Blood Grouping Reagent, Anti-D (Monoclonal)(IgM)(Formulated for Automated Testing)
To include a new indication for your Blood Grouping Reagents (BGRs) as reactive components of a buffered-----(b)(4)----- gel suspension filled into the IH-Cards. The BGRs will be used for the detection and identification of blood grouping antigens based on the principles of hemagglutination and gel filtration. The IH-Cards are intended to be used on the IH-1000 Automated Analyzer System for ABO/RhD grouping and Rh/Kell Phenotyping. 125097/67

Bio-Rad Medical Diagnostics GmbH

Industriestrasse 1, D-63303 Dreieich
Germany

Lic. #1845
10/20/2016

IH-Card Rh-Phenotype+K;
IH-Card Anti-E;
IH-Card Anti C-E-K;
IH-Card RhD(DVI-)+Phenotype

Blood Grouping Reagent, Anti-E (Monoclonal)(Formulated for Automated Testing)

To include a new indication for your Blood Grouping Reagents (BGRs) as reactive components of a buffered-----(b)(4)----- gel suspension filled into the IH-Cards. The BGRs will be used for the detection and identification of blood grouping antigens based on the principles of hemagglutination and gel filtration. The IH-Cards are intended to be used on the IH-1000 Automated Analyzer System for ABO/RhD grouping and Rh/Kell Phenotyping.

125202/50

Bio-Rad Medical Diagnostics GmbH

Industriestrasse 1, D-63303 Dreieich
Germany

Lic. # 1845

10/20/2016

IH-Card Rh-Phenotype+K;
IH-Card Anti-e;
IH-Card RhD(DVI-)+Phenotype

Blood Grouping Reagent, Anti-e (Monoclonal)(Formulated for Automated Testing)
To include a new indication for your Blood Grouping Reagents (BGRs) as reactive components of a buffered-----(b)(4)----- gel suspension filled into the IH-Cards. The BGRs will be used for the detection and identification of blood grouping antigens based on the principles of hemagglutination and gel filtration. The IH-Cards are intended to be used on the IH-1000 Automated Analyzer System for ABO/RhD grouping and Rh/Kell Phenotyping. 125203/48

Bio-Rad Medical Diagnostics GmbH

Industriestrasse 1, D-63303 Dreieich
Germany

Lic. # 1845
10/20/2016

IH-Card Rh-Phenotype+K;
IH-Card Anti-e;
IH-Card RhD(DVI-)+Phenotype

Blood Grouping Reagent, Anti-K (Monoclonal)(Formulated for Automated Testing)

To include a new indication for your Blood Grouping Reagents (BGRs) as reactive components of a buffered-----(b)(4)----- gel suspension filled into the IH-Cards. The BGRs will be used for the detection and identification of blood grouping antigens based on the principles of hemagglutination and gel filtration. The IH-Cards are intended to be used on the IH-1000 Automated Analyzer System for ABO/RhD grouping and Rh/Kell Phenotyping.

125204/46

Bio-Rad Medical Diagnostics GmbH

Industriestrasse 1, D-63303 Dreieich
Germany

Lic. #1845

10/20/2016

IH-Card Rh-Phenotype+K;
IH-Card Anti-c;
IH-Card RhD(DVI-)+Phenotype

Blood Grouping Reagent, Anti-C (Monoclonal)(Formulated for Automated Testing)

To include a new indication for your Blood Grouping Reagents (BGRs) as reactive components of a buffered-----(b)(4)----- gel suspension filled into the IH-Cards. The BGRs will be used for the detection and identification of blood grouping antigens based on the principles of hemagglutination and gel filtration. The IH-Cards are intended to be used on the IH-1000 Automated Analyzer System for ABO/RhD grouping and Rh/Kell Phenotyping. 125205/46

Bio-Rad Medical Diagnostics GmbH

Industriestrasse 1, D-63303 Dreieich
Germany

Lic. # 1845

10/20/2016

IH-Card Rh-Phenotype+K;
IH-Card Anti-C;
IH-Card Anti C-E-K;
IH-Card RhD(DVI-)+Phenotype

Blood Grouping Reagent, Anti-C (Monoclonal)(Formulated for Automated Testing)

To include a new indication for your Blood Grouping Reagents (BGRs) as reactive components of a buffered-----(b)(4)----- gel suspension filled into the IH-Cards. The BGRs will be used for the detection and identification of blood grouping antigens based on the principles of hemagglutination and gel filtration. The IH-Cards are intended to be used on the IH-1000 Automated Analyzer System for ABO/RhD grouping and Rh/Kell Phenotyping. 125206/48

Bio-Rad Medical Diagnostics GmbH

Industriestrasse 1, D-63303 Dreieich
Germany

Lic. # 1845

10/20/2016

IH-Cell A1 & B;
IH-Cell A2;
IH-Cell I-II;
IH-Cell I-II-III;
IH-Cell Pool;
IH-Panel 11;
IH-Panel 11 Papain;
IH-Panel Plus 6

Reagent Red Blood Cells For Use in Automated Systems
To include its use in IH-Red Blood Cell products for the detection and identification of ABO serum grouping, and detection and identification of unexpected antibodies, based on the principles of hemagglutination and gel filtration of the IH-Card System. The IH-Cell products are intended to be used on the IH-1000 Automated Analyzer System. 125208/70

Bio-Rad Medical Diagnostics GmbH

Industriestrasse 1, D-63303 Dreieich
Germany

Lic. # 1845
10/20/2016

Antihuman Globulin, Anti-IgG Solidscreen II

Anti-Human Globulin (Formulated for Automated Testing)

To include its use in the IH-AHG Card Anti-IgG for the detection and identification of clinically relevant antibodies, cross matching and Direct Antiglobulin Tests (DAT), based on the principles of hemagglutination and gel filtration at your location in Dreieich, Germany. The IH-AHG Card Anti-IgG product is intended to be used on the IH-1000 Automated Analyzer System. 125098/88

Bio-Rad Medical Diagnostics GmbH

Industriestrasse 1, D-63303 Dreieich
Germany

Lic. #1845

10/20/2016

FluBlok

Influenza Vaccine

To include a quadrivalent formulation (Flublok® Quadrivalent), for use in persons 18 years of age and older and to include the data from the confirmatory clinical study to verify and describe the clinical benefit of Flublok (trivalent formulation) in person 50 years of age and older.

 125285/194

Protein Sciences Corporation

1000 Research Parkway, Meriden CT 06450

Lic. # 1795

10/7/2016

Gardasil 9

Human Papillomavirus 9-valent Vaccine, Recombinant
To include a 2-dose regimen for individuals 9 through 14 years of age. 125508/153

Merck Sharp & Dohme Corp.

1 Merck Drive, Whitehouse Station, NJ 08889-0100

Lic.# 0002
10/7/2016

EVARREST

Fibrin Sealant Patch
To expand the clinical indication of EVARREST to include use with manual compression as an adjunct to hemostasis in adult patients undergoing surgery, when control of bleeding by conventional surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. 125392/163

Ethicon, Inc.

P. O. Box 151, Route 22 West, Somerville, NJ 08876-0151

Lic. # 1879
10/7/2016
Daptacel
Diphtheria & Tetanus Toxoids & Acellular Pertussis Vaccine Adsorbed
To include immunogenicity and safety data to support the co-administration of Meningococcal (Groups A, C, Y and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine (Menactra) with a fifth dose of DAPTACEL in children 4 through 6 years of age. 103666/5377 Sanofi Pasteur Limited
1755 Steeles Avenue West,
Toronto, Ontario,
M2R 3T4, Canada

Lic. # 1726
9/16/2016
Menactra
Meningococcal Groups (A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
To include immunogenicity and safety data to support the co-administration of Menactra with a fifth dose of Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed (DAPTACEL) in children 4 through 6 years of age. 125089/593 Sanofi Pasteur Inc.
Discovery Drive,
Swiftwater, PA, 18370-0187

Lic. # 1725
9/16/2016
Q-Pan
Influenza A (H5N1) Virus Monovalent Vaccine, Adjuvanted
To extend the age range for use to include persons 6 months through 17 years of age at increased risk of exposure to the influenza A virus H5N1 subtype contained in the vaccine. 125419/39 D Biomedical Corporation of Quebec
2323 Technology Park Boulevard,
Sainte-Foy, G1P 4R8, Canada

Lic. # 1739
9/9/2016
Prevnar 13
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
To include language in the US Package Insert (USPI) for the use of Prevnar 13® in subjects who have received a Hematopoietic Stem Cell Transplant. 125324/1373 Wyeth Pharmaceuticals Inc.
401 North Middletown Rd,
Pearl River, NY, 10965

Lic # 3
8/31/2016
Prevnar 13
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
To update to the United States Prescribing Information (USPI) to include information regarding the use of Prevnar 13®, in subjects infected with human immunodeficiency virus (HIV). 125324/1371 Wyeth Pharmaceuticals Inc.
401 North Middletown Rd,
Pearl River, NY, 10965

Lic # 3
8/31/2016
AFLURIA
Influenza Vaccine
To include a quadrivalent formulation (Afluria® Quadrivalent) for use in persons 18 years of age and older. 125254/565 Seqirus Pty Ltd.
45 Poplar Road, Parkville,
Victoria, 01, 3052

Lic #2044
8/26/2016
Berinert
C1 Esterase Inhibitor (Human)
Pediatric Age Group Indication Extension and Geriatric Experience Label Update 125287/288 CSL Behring GmbH
1020 First Avenue,
King of Prussia, PA, 19406-0901

Lic # 1765
7/15/2016
Prevnar 13
Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)
To expand the indication to include adults 18 through 49 years of age. 125324/1358 Wyeth Pharmaceuticals Inc.
401 North Middletown Rd,
Pearl River, NY, 10965

Lic # 3
7/11/2016

Flucelvax Quadrivalent
Influenza Vaccine

To extend the age range for use of Flucelvax® to include persons 4 years to <18 years of age according to the regulations for accelerated approval, 21 CFR 601.40-46. 125408/101

Seqirus Inc.
75 Sidney Street, Cambridge, MA, 02139

Lic. # 2049
05/23/2016

Flucelvax Quadrivalent
Influenza Vaccine

To include a quadrivalent formulation (Flucelvax® Quadrivalent), for use in persons 4 years of age and older. For the age group 4 years to <18 years of age, we have approved your request to supplement your BLA for Influenza Vaccine according to the regulations for accelerated approval, 21 CFR 601.40-46. 125408/127

Seqirus Inc.
75 Sidney Street, Cambridge, MA, 02139

Lic. # 2049

05/23/2016
TRUMENBA
Meningococcal Group B Vaccine
To include a two-dose schedule (a dose administered at 0 and 6 months) according to the regulations for accelerated approval, and a modification of the three-dose schedule from administration at 0, 2, and 6 months to administration at 0, 1-2, and 6 months. 125549/17 Wyeth Pharmaceuticals Inc.
401 North Middletown Rd,
Pearl River, NY, 10965

Lic. # 3
4/14/2016
Hiberix
Haemophilus b Conjugate Vaccine (Tetanus Toxoid Conjugate)
To support use of HIBERIX for active immunization for the prevention of invasive disease caused by Haemophilus influenzae type b in children 6 weeks to 14 months of age. 125347/231 GlaxoSmithKline Biologicals
Rue de l'Institut 89,
B1330 Rixensart, MA,Belgium

Lic. # 1617
1/14/2016
Flebogamma 5%; Flebogamma; Flebogamma 5% DIF
Immune Globulin Intravenous (Human)
Treatment of Chronic Primary Immune Thrombocytopenia (ITP) 125077/332 Instituto Grifols, S.A.
#2 Can Guasch St, Poligono Levante,
08150 Parets Del Valles,
Barcelona, Spain

Lic. # 1181
1/8/2016
ELOCTATE
Antihemophilic Factor (Recombinant), Fc Fusion protein
To support labeling changes based on additional final efficacy, pharmacokinetic (PK), and safety data from the completed pediatric study (8HA02PED) and interim efficacy and safety data regarding inhibitor development from the completed pediatric study and ongoing extension study (8HA01EXT). 125487/99 Biogen Inc.
14 Cambridge Center,
Cambridge, MA, 02142

Lic. # 1697
1/8/2016