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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

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

1/31/14

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

1/31/14

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

1/31/14