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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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2014 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.

Tradename/
Proper
 Name              
Indication for Use             
STN
Manufacturer/
License No.
Approval Date

RIXUBIS

Coagulation Factor IX (Recombinant)
 

For the final pediatric (< 6 years of age to 12 years of age) clinical study report for pharmacokinetics, hemostatic efficacy, safety, immunogenicity and changes in health related quality of life for your product, risk management plan, clinical data and revised package insert. [s/b final pediatric patients under 12 years of age]
 

B125446/31
 

Baxter Healthcare Corporation One Baxter Way Westlake Village CA 91362

Lic# 0140

9/12/2014
 

Menactra

Meningococcal Groups (A, C, Y, and W-135) Polysaccharide Diphtheria Toxoid Conjugate Vaccine
 

To revise the package insert to include safety and immunogenicity data to support Menactra revaccination at 15 years through 55 years of age in adolescents and adults at continued risk for meningococcal disease, if at least 4 years have elapsed since the prior dose.
 

B125089/549
 

Sanofi Pasteur Inc. Discovery Drive Swiftwater PA 18370-0187

Lic# 1725
 

9/04/2014
 

Flebogamma DIF 5%

Immune Globulin Intravenous (Human)
 

Revised package circular to reflect the pediatric age groups studied in the postmarketing study (IG0705) submitted on May 25, 2012 under BL 125077/252.
 

B125077/296
 

Instituto Grifols, S.A. #2 Can Guasch St Barcelona 

Lic# 1181

8/19/2014

AFLURIA

Influenza Vaccine
 

To update the package insert to include the data to support the use of PharmaJet® Stratis® Needle-Free Injection System, in addition to traditional needle and syringe, for the intramuscular administration of AFLURIA.
 

B125254/511
 

bioCSL Pty Ltd 63 Poplar Road
Parkville, Victoria 3052
Australia

8/15/2014

Kinrix

Diphtheria and Tetanus Toxoids and Acellular Pertussis Vaccine Adsorbed and Inactivated Poliovirus Vaccine

To revise the package insert to include safety and immunogenicity data to support co-administration of Kinrix with varicella virus vaccine and to update the pharmacovigilance plan.

B125260/364

GlaxoSmithKline Biologicals
Rue de l'Institut 89 B1330 Rixensart
Belgium 

Lic# 1617

7/23/2014

Cervarix

Human Papillomavirus Bivalent (Types 16 and 18) Vaccine, Recombinant

To include efficacy and immunogenicity data from the end-of-study analyses of Study HPV-008 in the package insert and to update the pharmacovigilance plan.

B125259/301

GlaxoSmithKline Biologicals
Rue de l'Institut 89 B1330 Rixensart, Belgium 

Lic# 1617

7/21/2014

OCTAGAM

Immune Globulin Intravenous (Human)

OCTAGAM 10% is an immune globulin intravenous (human) liquid preparation indicated for the treatment of chronic immune thrombocytopenic purpura (ITP) in adults

B125062/234

Octapharma Pharmazeutika Produktionsges. m.b.H.
Oberlaaer Strasse 235 Vienna, Austria 

Lic# 1646

7/11/2014

NovoSeven; NovoSeven RT

Coagulation Factor VIIa (Recombinant)

For treatment and perioperative management in adults and children with Glanzmann’s thrombasthenia with refractoriness to platelet transfusions, with or without antibodies to platelets.

B103665/5834

Novo Nordisk Inc. 100 College Road West Princeton NJ 8540

Lic# 1261

7/2/2014

Kogenate; Helixate FS; Kogenate FS

Antihemophilic Factor (Recombinant) 

Expanding the indication of Kogenate FS to include adult prophylaxis. 

B103332/6409 

Bayer HealthCare LLC
800 Dwight Way Berkeley CA 94701

Lic # 0008

5/9/2014 

ADACEL

Tetanus Toxoid, Reduced Diphtheria Toxoid and Acellular Pertussis Vaccine, Adsorbed
 

To lower the age indication for Adacel administration from 11 to 10 years of age.
 

B125111/509
 

Sanofi Pasteur Limited 1755 Steeles Avenue West Toronto, Ontario  M2R 3T4

Lic# 1726

3/28/2014
 

Glassia

Alpha-1-Proteinase Inhibitor (Human)
 

To provide clinical safety and tolerability data with a revised package insert for the increase of the maximum recommended intravenous infusion rate from 0.04 mL/kg/min to 0.2 mL/kg/min.
 

B125325/149
 

Kamada Ltd. 7 Sapir Street
Ness Ziona, 74140
Israel

Lic# 1826

3/19/2014
 

Aralast

Aralast NP/Alpha-1-Proteinase Inhibitor (Human)
 

Changes to the package insert to conform to the Physicians' Labeling Rule, changes to the vial labels and unit cartons, increase in the maximal rate of product infusion, addition of safety and surrogate efficacy data from Bronchoalveolar Lavage study 460502, and addition of postmarketing adverse event data and nonclinical toxicology data.
 

B125039/814
 

Baxter Healthcare Corporation One Baxter Way Westlake Village CA 91362

Lic# 0140
 

3/17/2014
 

Prevnar 13

Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

To include text in the US Prescribing Information (USPI) for the use of Prevnar 13® in children and adolescents aged 6 to <18 years with sickle cell disease (SCD).
 

L125324/933 

Wyeth Pharmaceuticals Inc. 401 North Middletown Rd Pearl River NY 10965

Lic#0003

1/31/2014

Prevnar 13

Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

To include text in the US Prescribing Information (USPI) for the use of Prevnar 13® in preterm infants (< 37 weeks of gestational age).
 

L125324/934

Wyeth Pharmaceuticals Inc. 401 North Middletown Rd Pearl River NY 10965

Lic#0003

1/31/2014

Prevnar 13

Pneumococcal 13-valent Conjugate Vaccine (Diphtheria CRM197 Protein)

To include text in the US Prescribing Information (USPI) for the use of Prevnar 13® in HIV-Infected adults ≥ 50 years of age.
 

L125324/950

Wyeth Pharmaceuticals Inc. 401 North Middletown Rd Pearl River NY 10965

Lic#0003

1/31/2014