Vaccines, Blood & Biologics

2014 Biological License Application Approvals

This list reflects information regarding the applications as of the approval date. It is not updated with regard to applicant or application status changes. The applications are listed by date of approval.

2014 Biological License Application Approvals
Tradename/
Proper Name
Indication for UseSTNManufacturer/
License Number
Approval Date

Source Plasma
 

Original BLA for SP center located at 1000 Broadway Drive, Suite 42, Hattiesburg, MS (FEI 3010749979). Center to collect SP from normal donors for manufacture into injectable products. 
 

125548/0
 

Immunotek Bio Centers, LLC 3900 N. Causeway, Suite 1200 Metairie LA 70002

Lic # 2000
 

12/22/2014

cobas® TaqScreen MPX Test, version 2.0

/HIV-1 Group O and M, HIV-2, HCV and/or HBV (HIV-1/HIV-2/HCV/HBV/Multiplex Discriminatory NAT)
 

A qualitative in vitro test for the direct detection of HIV-1 Group M RNA, HIV-2 Group O RNA, HIV-2 RNA, HCV RNA, and HBV DNA in human plasma
 

125459/0
 

Roche Molecular Systems, Inc. 4300 Hacienda Dr Pleasanton CA 94588-2722

Lic# 1636
 

12/19/2014

 

MP Diagnostics HTLV Blot 2.4

Human T-Lymphotropic Virus Types I & II
 

A qualitative enzyme immunoassay intended for confirming the presence of and differentiating antibodies to HTLV-I and HTLV-II in human serum and plasma.  It is intended for use as a supplemental (additional, more specific) test for human serum and plasma specimens with repeatedly reactive results by an FDA-licensed HTLV-I/II donor screening test.  This test is not intended for use in medical diagnosis.  It is intended for use in a manual mode or a semi-automated mode using the MP Diagnostics AutoBlot System 20.  [placed on eCopy and User Fee Hold]
 

125475/0
 

MP Biomedicals Asia Pacific Pte. Ltd. 2 Pioneer Place Singapore  627885

Lic # 1897
 

12/11/2014
 

Gardasil 9

Human Papillomavirus 9-valent Vaccine, Recombinant
 

Indicated in girls and women 9 through 26 years of age; and in boys 9 through 15 years of age. 
 

125508/0
 

Merck Sharp & Dohme Corp.
P.O. Box 4 West Point PA 19486-0004

Lic # 2

12/10/2014
 

TRUMENBA

Meningococcal Group B Vaccine

Active immunization to prevent invasive meningococcal disease caused by N. meningitidis serogroup B in individuals 10 through 25 years of age.
 

 125549/0

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

Lic# 0003

10/29/2014

OBIZUR

Antihemophilic Factor (Recombinant), Porcine Sequence
 

OBIZUR, Antihemophilic Factor (Recombinant), Porcine Sequence, indicated for the treatment of bleeding episodes in adults with acquired hemophilia A (acquired inhibitory antibodies to human factor VIII).
 

 125512/0

Baxter Healthcare Corporation
One Baxter Way Westlake Village CA 91362

Lic# 0140

 10/23/2014

HYQVIA

Immune Globulin Infusion (Human), 10% with Recombinant Human Hyaluronidase
 

Indicated for the treatment of humoral immune defects in adults with Primary Immunodeficiency (PI)
 

125402/0

Baxter Healthcare Corporation One Baxter Way Westlake Village CA 91362

Lic# 0140

9/12/2014

RUCONEST

C1 Esterase Inhibitor (Recombinant)

Treatment of acute attacks of hereditary angioedema (HAE) in adult and adolescent patients

125495/0

Pharming Group NV Darwinweg 24 2333 CR Leiden 

Lic# 1857

7/16/2014

ELOCTATE

Antihemophilic Factor (Recombinant), Fc Fusion protein

Treatment of adults and children with Hemophilia A for the following indications:  control and prevention of bleeding episodes; routine prophylaxis to prevent or reduce the frequency of bleeding episodes; and perioperative management (surgical prophylaxis)

125487/0

Biogen Idec Inc.
14 Cambridge Center
Cambridge MA
02142

Lic # 1697

6/6/2014

Blood Grouping Reagent, Anti-Jka (Monoclonal)

Gamma-clone® Anti-Jka Monoclonal Blood Grouping Reagent

Cell Line: MS-15

125489/0

Immucor, Inc. 3130 Gateway Drive Norcross GA 30091-5625

Lic # 0886

5/5/2014

Blood Grouping Reagent, Anti-Jkb (Monoclonal)

Gamma-clone® Anti-Jkb Monoclonal Blood Grouping Reagent

Cell Line:  MS-8

125490/0

Immucor, Inc. 3130 Gateway Drive Norcross GA 30091-5625

Lic # 0886

5/5/2014

Blood Grouping Reagent, Anti-S (Monoclonal)

Gamma-clone® Anti-S Monoclonal Blood Grouping Reagent

Cell Line:  MS-94

125491/0

Immucor, Inc. 3130 Gateway Drive Norcross GA 30091-5625

Lic # 0886

5/5/2014

Blood Grouping Reagent, Anti-s (Monoclonal)

Gamma-clone® Anti-s, Monoclonal Blood Grouping Reagent

Cell Line:  P3BER

125492/0

Immucor, Inc. 3130 Gateway Drive Norcross GA 30091-5625

Lic # 0886

5/5/2014

Blood Grouping Reagent, Anti-Fya (Monoclonal) (IgG)

Gamma-clone® Anti-Fya Monoclonal Blood Grouping Reagent

Cell Line:  P3TIM

125493/0

Immucor, Inc. 3130 Gateway Drive Norcross GA 30091-5625

Lic # 0886

5/5/2014

Blood Grouping Reagent, Anti-Fya (Monoclonal)

Further Manufacturing Use Anti-Fya, Cell Line P3TIM Product Code:
--b(4)-----

125497/0

Millipore (UK) Ltd. EMD Millipore Corporation
290 Concord Road
Billerica, MA 01821

Lic # 1761

5/5/2014

Blood Grouping Reagent, Anti-s (Monoclonal)

Further Manufacturing Use Anti-s, Cell Line P3BER, Product Code: -b(4)------

125498/0

Millipore (UK) Ltd. EMD Millipore Corporation
290 Concord Road
Billerica, MA 01821

Lic # 1761

5/5/2014

RAGWITEK  

Short Ragweed Pollen Allergen Extract

Indicated as immunotherapy for the treatment of short ragweed pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen specific IgE antibodies for short ragweed pollen. Approved for use in adults 18 through 65 years of age.

125478/0

Merck Sharp & Dohme Corp.P.O. Box 4West PointPA19486-0004

4/17/2014

GRASTEK  

Timothy Grass Pollen Allergen Extract

Timothy Grass Pollen Allergen Extract is indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis, with or without conjunctivitis, confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for Timothy grass or cross-reactive grass pollens. Timothy Grass Pollen Allergen Extract is approved for use in persons 5 through 65 years of age.

125473/0

Merck Sharp & Dohme Corp.P.O. Box 4West PointPA19486-0004

4/11/2014

ORALAIR  
 

Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract

Indicated as immunotherapy for the treatment of grass pollen-induced allergic rhinitis with or without conjunctivitis confirmed by positive skin test or in vitro testing for pollen-specific IgE antibodies for any of the five grass species contained in this product. ORALAIR is approved for use in persons 10 through 65 years of age.

125471/0

Stallergenes, S.A.6 rue Alexis de TocquevilleAntony Cedex

4/1/2014

ALPROLIX 
 

Coagulation Factor IX (Recombinant), Fc Fusion Protein

Treatment of hemophilia B for:  1. Control and prevention of bleeding episodes; 2. Routine prophylaxis to prevent or reduce the frequency of bleeding episodes;  3. Perioperative management (surgical prophylaxis)

125444/0

Biogen Idec Inc. 14 Cambridge Center, Cambridge MA 02142

Lic# 1697

3/28/2014

 

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