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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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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.

Tradename/
Proper Name
Indication for UseSTNManufacturer/
License Number
Approval Date

RUCONEST

C1 Esterase Inhibitor (Recombinant)

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

B125495/0

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)

B 125487/0

Biogen Idec Inc.
14 Cambridge Center
Cambridge MA
02142

Lic # 1697
06/06/14
Blood Grouping Reagent, Anti-Jka (Monoclonal)Gamma-clone® Anti-Jka Monoclonal Blood Grouping Reagent

Cell Line: MS-15
B125489/0

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

Lic # 0886
5/5/14
Blood Grouping Reagent, Anti-Jkb (Monoclonal)

Gamma-clone® Anti-Jkb Monoclonal Blood Grouping Reagent

Cell Line:  MS-8

B125490/0

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

Lic # 0886

5/5/14
Blood Grouping Reagent, Anti-S (Monoclonal)

Gamma-clone® Anti-S Monoclonal Blood Grouping Reagent

Cell Line:  MS-94

B125491/0

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

Lic # 0886

5/5/14
Blood Grouping Reagent, Anti-s (Monoclonal)

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

Cell Line:  P3BER

B125492/0

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

Lic # 0886

5/5/14
Blood Grouping Reagent, Anti-Fya (Monoclonal) (IgG)

Gamma-clone® Anti-Fya Monoclonal Blood Grouping Reagent

Cell Line:  P3TIM

B125493/0

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

Lic # 0886

5/5/14
Blood Grouping Reagent, Anti-Fya (Monoclonal) Further Manufacturing Use Anti-Fya, Cell Line P3TIM Product Code:
--b(4)-----
B125497/0

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

Lic # 1761

5/5/14
Blood Grouping Reagent, Anti-s (Monoclonal) Further Manufacturing Use Anti-s, Cell Line P3BER, Product Code: -b(4)------B125498/0

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

Lic # 1761

5/5/14
RAGWITEK   Short Ragweed Pollen Allergen ExtractIndicated 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.B125478/0Merck Sharp & Dohme Corp.P.O. Box 4West PointPA19486-000404/17/14
GRASTEK   Timothy Grass Pollen Allergen ExtractTimothy 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.B125473/0Merck Sharp & Dohme Corp.P.O. Box 4West PointPA19486-000404/11/14
ORALAIR   Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen ExtractIndicated 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.B125471/0Stallergenes, S.A.6 rue Alexis de TocquevilleAntony Cedex04/01/14

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)

B125444/0

Biogen Idec Inc. 14 Cambridge Center, Cambridge MA 02142

Lic# 1697

3/28/2014