2017 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 Use | STN | Manufacturer/ License Number |
Approval Date |
|---|---|---|---|---|
| LUXTURNA Voretigene Neparvovec |
Indicated for the treatment of patients with confirmed biallelic RPE65 mutation-associated retinal dystrophy | BLA 125610/0 | Spark Therapeutics, Inc. 3737 Market Street, Suite 1300, Philadelphia, PA, 19104 Lic# 2056 |
12/19/2017 |
| HEPLISAV-B Hepatitis B Vaccine (Recombinant), Adjuvanted |
Hepatitis B Vaccine(Recombinant), Adjuvanted is indicated for immunization against infection caused by all known subtypes of hepatitis B virus. Hepatitis B Vaccine (Recombinant), Adjuvanted is approved for use in adults 18 years of age and older. | 125428/0 | Dynavax Technologies Corporation 2929 Seventh Street, Suite 100 Berkeley, CA 94710 Lic # 1883 |
11/9/2017 |
| Fibrin Sealant (Human) | The Fibrin Sealant (Human) is indicated for use as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. Fibrin Sealant (Human) is effective in heparinized patients. | 125640/0 | Instituto Grifols, S.A. #2 Can Guasch St, Poligono Levante 08150 Parets Del Valles Barcelona, Spain Lic # 1181 |
11/1/2017 |
| SHINGRIX Zoster Vaccine Recombinant, Adjuvanted) |
Prevention of herpes zoster (shingles) in adults aged 50 years and older. | 125614/0 | GlaxoSmithKline Biologicals Rue de l'Institut 89, B1330 Rixensart, Belgium Lic # 1617 |
10/20/2017 |
| YESCARTA axicabtagene ciloleucel |
Indicated for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high grade B-cell lymphoma, and DLBCL arising from follicular lymphoma. Axicabtagene ciloleucel is not indicated for the treatment of patients with primary central nervous system lymphoma. | 125643/0 | Kite Pharma Inc. 2225 Colorado Avenue, Santa Monica, CA, 90404 Lic # 2064 |
10/18/2017 |
| Anti-Human Globulin (Rabbit/Murine Monoclonal) | Anti- Human Globulin (Rabbit/Murine Monoclonal) is intended for use in the direct antiglobulin test to detect the in vivo coating of human red blood cells with IgG and/or C3b and/or C3d components and the indirect antiglobulin test to detect the in vitro coating of human red blood cells with IgG and/or C3b and/or C3d components. | 125465/0 | Alba Bioscience Limited Ellen's Glen Road, Edinburgh EH17 7QT, United Kingdom Lic # 1807 |
10/15/2017 |
| cobas® Zika, Nucleic acid test for use on the cobas® 6800/8800 systems cobas Zika |
The cobas® Zika for use on the cobas® 6800 and cobas® 8800 Systems is a qualitative in vitro nucleic acid screening test for the direct detection of Zika virus RNA in human plasma. This test is intended for use to screen donor samples for Zika virus RNA in plasma samples from individual human donors, including donors of whole blood and blood components, and other living donors. This test is also intended for use to screen organ and tissue donors when donor samples are obtained while the donor’s heart is still beating. Plasma from all donors should be screened as individual samples. The test is not intended for use as an aid in diagnosis of Zika virus infection. This test is not intended for use on samples of other body fluids. This test is not intended for use on samples of cord blood. | 125653/0 | Roche Molecular Systems, Inc. 4300 Hacienda Dr, Pleasanton, CA, 94588-2722 Lic # 1636 |
10/5/2017 |
| Anti-Human Globulin | A bundled submission for the following 3 products Anti-IgG, -C3d Polyspecific (Rabbit Polyclonal and Murine Monoclonal), product code Z350U - (FDA's name: an Globulin (Rabbit/Murine Monoclonal) Anti-IgG (Rabbit Polyclonal), product code Z356U - (FDA's name: Anti-Human Globulin) Anti-C3d ALBAclone (Murine Monoclonal IgG), product code Z360U - (FDA's name: Anti-Human Globulin (Murine Monoclonal)) | 125464/0 | Alba Bioscience Limited Ellen's Glen Road, Edinburgh EH17 7QT, United Kingdom Lic # 1807 |
9/21/2017 |
| Anti-Human Globulin (Murine Monoclonal) | A bundled submission for the following 3 products. Anti-IgG, -C3d Polyspecific (Rabbit Polyclonal and Murine Monoclonal), product code Z350U - (FDAs name: an Globulin (Rabbit/Murine Monoclonal) Anti-IgG (Rabbit Polyclonal), product code Z356U - ( FDAs name: Anti-Human Globulin) Anti-C3d ALBAclone (Murine Monoclonal IgG), product code Z360U - (FDAs name: Anti-Human Globulin (Murine Monoclonal)) | 125463/0 | Alba Bioscience Limited Ellen's Glen Road, Edinburgh EH17 7QT, United Kingdom Lic # 1807 |
9/21/2017 |
| KYMRIAH Tisagenlecleucel |
For the treatment of patients up to 25 years of age with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse. | 125646/0 | Novartis Pharmaceuticals Corporation 59 Route 10, East Hanover, NJ, 07936-1080 Lic # 1244 |
8/30/2017 |
| KEDRAB Rabies Immune Globulin (Human) |
For Passive, transient post-exposure prophylaxis (PEP) of rabies infection, when given immediately after contact with a rabid or possibly rabid animal. Rabies Immune Globulin (Human) should be administered concurrently with a full course of rabies vaccine. | 125613/0 | Kamada Ltd. 7 Sapir Street, Ness Ziona, 74140, Israel Lic # 1826 |
8/23/2017 |
| Blood Grouping Reagent, Anti-Fyb (Human/Murine Monoclonal) | Blood Grouping Reagent, Anti-Fyb (Human/Murine Monoclonal) is indicated for the Direct Agglutination Test by Tube Technique for the qualitative in vitro detection and identification of human Fyb positive red blood cells. | 125637/0 | Alba Bioscience Limited Ellen's Glen Road, Edinburgh EH17 7QT, United Kingdom Lic # 1807 |
07/7/2017 |
| Blood Grouping Reagent, Anti-Fyb (Monoclonal) (For Further Manufacturing Use) | Anti- Fyb Human Monoclonal (lgM) Blood Grouping Reagent for Further Manufacturing Use (FFMU) Cell Line: ------------------------------------ ----------------- ------------------------------------ --------------------------(b)(4)------------------------------------------------------------- ------------------------------------------------- ------------------------ |
125638/0 | Millipore (UK) Ltd. Fleming Road, Livingston, EH54 7BN, United Kingdom Lic # 1761 |
07/7/2017 |
| HAEGARDA C1 Esterase Inhibitor Subcutaneous (Human) |
C1 Esterase Inhibitor Subcutaneous (Human) is indicated for routine prophylaxis to prevent Hereditary Angioedema (HAE) attacks in adolescent and adult patients. | 125606/0 | CSL Behring GmbH 1020 First Avenue, King of Prussia, PA, 19406-0901 Lic # 1765 |
6/22/2017 |
| Blood Grouping Reagent, Anti-N (Murine Monoclonal)(IgG)(For Further Manufacturing Use) | The Blood Grouping Reagent, Anti-N(Murine Monoclonal)(IgG)(For Further Manufacturing Use) is indicated for use in the manufacture of in vitro product Blood Grouping Reagent, Anti-N (Murine Monoclonal) IgG by -------------------------------(b)(4)-------------------------, under a shared manufacturing arrangement. | 125583/0 | Millipore (UK) Ltd. Fleming Road, Livingston, EH54 7BN, United Kingdom Lic # 1761 |
6/16/2017 |
| FIBRYGA Fibrinogen (Human) |
Fibrinogen (Human) is indicated for the treatment of acute bleeding episodes in adults and adolescents ≥ 12 years of age with congenital fibrinogen deficiency, including afibrinogenemia and hypofibrinogenemia. | 125612/0 | Octapharma Pharmazeutika Produktionsges.m.b.H. Oberlaaer Strasse 235, Vienna Lic # 1646 |
06/7/2017 |
| REBINYN Coagulation Factor IX (Recombinant), GlycoPEGylated |
Indicated for use in adults and children with hemophilia B for:
|
125611/0 | Novo Nordisk Inc. 100 College Road West, Princeton, NJ, 08540 Lic # 1261 |
05/31/2017 |
| [Multiple Products: Human Blood and Blood Components] | To supplement this biologics license application for Whole Blood and blood components to include the manufacture of of Red Blood Cells, Leukocytes Reduced and Apheresis Red Blood cells, Leukcytes Reduced utilizing the ---(b)(4)----------------------------- to supplement this biologics license application for Whole Blood and blood components to include --(b)(4)----------- --(b)(4)------------------------------- --------------------------------------------- ---------------------------------------- ------------------------------------------------------------------------------------------- as the testing laboratories to perform FDA required or recommended donor assays. | 125396/0 | Stanford Blood Center 3373 Hillview Avenue, Palo Alto, CA, 94304 Lic # 1858 |
03/29/2017 |
| Blood Grouping Reagent, Anti-Jkb (Monoclonal) (IgM) (For Further Manufacturing Use) Blood Grouping Reagent, Anti-Jka (Monoclonal) (IgM) (For Further Manufacturing Use), Blood Grouping Reagent, Anti-S (Monoclonal) (IgG) (For Further Manufacturing Use) |
Blood Grouping Reagents, Anti-Jkb (Monoclonal)(IgM), Anti-Jka (Monoclonal) (IgM), Anti-S (Monoclonal) (IgG) for For Further Manufacturing Use(FFMU) to be used by -(b)(4)- ------------------- intended for future manufacturing use in production of Blood Grouping Reagents for blood sample phenotyping. | 125500/0 125501/0 125502/0 |
Diagast Parc Eurasante, Loos Cedex, 59374 France Lic # 1744 |
03/16/2017 |
| ORTHO™ Sera Anti- Fya, ORTHO™ Sera Anti-Jka, ORTHO™ Sera Anti-Jkb, ORTHO™ Sera Anti-S, ORTHO™ Sera Anti-s, ORTHO™ Sera Anti-K, ORTHO™ Sera Anti-P1 Blood Grouping Reagent Anti-Fya (Monoclonal)(IgG), Blood Grouping Reagent Anti-Jka (Monoclonal), Blood Grouping Reagent Anti-Jkb (Monoclonal), Blood Grouping Reagent Anti-S (Monoclonal)(IgG), Blood Grouping Reagent Anti-s (Monoclonal)(IgG), Blood Grouping Reagent Anti-K (Monoclonal), Blood Grouping Reagent Anti-P1 (Murine Monoclonal) |
The Blood Grouping Reagents is indicated to be used with the Ortho ID-Micro Typing System™ Gel System for the detection of blood group antigens Fya Jka, S, s, K, P1, on human red blood cells by Column Agglutination Technology (CAT). | 125567/0 125568/0 125569/0 125570/0 125571/0 125572/0 125573/0 |
Alba Bioscience Limited 21 Ellen's Glen Road, Edinburgh, Medlothian EH17 7QT United Kingdom Lic # 1807 |
03/16/2017 |
| Rubber Panel T.R.U.E. TEST Rubber Panel Thin-Layer Rapid Use Epicutaneous Patch Test |
Rubber Panel Thin-Layer Rapid Use Epicutaneous Patch Test is indicated for use as an aid in the diagnosis of allergic contact dermatitis in persons 6 years of age and older whose history suggests sensitivity to one or more of the five substances included on the Rubber Panel T.R.U.E. TEST. | 125579/0 | SmartPractice Denmark ApS 3400 East McDowell Road, Phoenix, AZ, 85008 Lic # 1888 |
03/3/2017 |
| Odactra House Dust Mites Allergenics Extract |
House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract is indicated as immunotherapy for house dust mite (HDM)-induced allergic rhinitis, with or without conjunctivitis, confirmed by in vitro testing for IgE antibodies to Dermatophagoides farinae or Dermatophagoides pteronyssinus house dust mites, or skin testing to licensed house dust mite allergen extracts. House Dust Mite (Dermatophagoides farinae and Dermatophagoides pteronyssinus) Allergen Extract is approved for use in adults 18 through 65 years of age. | 125592/0 | Merck Sharp & Dohme Corp. 1 Merck Drive, Whitehouse Station, NJ, 08889-0100 Lic # 2 |
03/1/2017 |