2018 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 |
|---|---|---|---|---|
| Noveoeight Antihemophilic Factor (Recombinant) |
To update the data from the NN7008-3568 and NN7008-3809 trials in the prescribing information label and to change the indication from “Control and prevention of bleeding episodes” to “on-demand treatment and control of bleeding episodes,” to change the frequency of dosing of adults and adolescents, to update the “Neutralizing Antibodies” section, to update the “ADVERSE REACTIONS” section, to update the “Immunogenicity” section, to update the “Pediatric Use” section, and to update the “CLINICAL STUDIES” section. | 125466/243 | Novo Nordisk Inc. P.O.Box 846, 800 Scudders Mill Road, Plainsboro, NJ 08536 Lic. # 1261 |
11/30/2018 |
| ORALAIR Sweet Vernal, Orchard, Perennial Rye, Timothy, and Kentucky Blue Grass Mixed Pollens Allergen Extract |
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 (for use in persons 10 through 65 years of age) | 125471/230 | Stallergenes, SAS 55 Cambridge Parkway, Suite 400 Cambridge, MA 02142 Lic. # 1893 |
11/09/2018 |
| Gardasil 9 Human Papillomavirus 9-valent Vaccine, Recombinant |
To extend the age range for the use of the vaccine to include women and men from 27 to 45 years of age. | 125508/493 | Merck Sharp & Dohme Corp. 1 Merck Drive, Whitehouse Station, NJ 08889-0100 United States Lic. #0002 |
10/05/2018 |
| Ixiaro Japanese Encephalitis Vaccine, Inactivated, Adsorbed |
To: i) include an alternate primary immunization series of tw0 0.5 mL doses of IXIARO administered at 7 days apart for indivuduals 18 through 65 years of age, and ii) update the IXIARO package insert to include data to support the concomitant use of IXIARO primary immunization series, two 0.5 mL doses administered 28 days apart, with U.S.-licensed rabies vaccine (RabAvert®) administered for pre-exposure prophylaxis. | 125280/251 | Valneva Austria GmbH Campus Vienna Biocenter 3, Vienna, A-1030 Austria Lic. # 1909 |
10/04/2018 |
| Afluria Quadrivalent, AFLURIA Influenza Vaccine |
To fulfill PREA PMR #2 from STN 125254/565 and extend the indication of Afluria and Afluria Quadrivalent to persons 6 through 59 months of age. | 125254/692 | Seqirus Pty Ltd. 45 Poplar Road, Parkville, Victoria, Australian Capital Territory 3052 Australia Lic. # 2044 |
10/04/2018 |
| COAGADEX Coagulation Factor X (Human) |
This is a PAS Efficacy Supplement submitted by BPL to BL 125506 for Coagulation Factor X (Human) [COAGADEX] for the following proposed indications for use with no age restrictions: (1) Routine prophylaxis to prevent or reduce the frequency of bleeding episodes; (2) on-demand treatment and control of bleeding episodes; and (3) perioperative management of bleeding in patients with mild hereditary Factor X deficiency |
125506/46 | Bio Products Laboratory Dagger Lane, Elstree, Hertfordshire, WD6 3BX United Kingdom Lic. # 1811 |
9/21/2018 |
| Blood Grouping Reagent, Anti-D (Monoclonal Blend) | To include the manufacture of Albaclone®Anti-D fusion at your facility located Edinburgh, Scotland, United Kingdom. Albaclone® Anti-D fusion is for the in vitro detection and identification of human RhoD blood group status in patient and donor samples by direct agglutination and indirect antiglobulin test using tube techniques. | 125314/50 | Alba Bioscience Limited Ellen's Glen Road, Edinburgh EH17 7QT, United Kingdom Lic. # 1807 |
6/22/2018 |
| Cinryze C1 Esterase Inhibitor (Human) |
To expand the indication for routine prophylaxis against angioedema attacks to include pediatric patients ages 6-11 with Hereditary Angioedema. | 125267/1356 | ViroPharma Biologics, Inc. 300 Shire Way, Lexington , MA, 02421 Lic # 1833 |
6/20/2018 |
| Procleix WNV Assay West Nile Virus (WNV/Nucleic Acid Pooled Testing/Synthetic) |
Qualitative in vitro nucleic acid amplification test to detect WNV RNA in human plasma. | 125121/80 | Grifols Diagnostics Solutions, Inc. 4560 Horton Street, Emeryville, CA, 94608-2916 Lic. # 2032 |
5/25/2018 |
| KYMRIAH Tisagenlecleucel |
To add a new indication for the treatment of adult patients with relapsed or refractory (r/r) large B-cell lymphoma after two or more lines of systemic therapy including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, high grade B-cell lymphoma and DLBCL arising from follicular lymphoma. | 125646/76 | Novartis Pharmaceuticals Corporation 59 Route 10, East Hanover, NJ, 07936-1080 Lic. # 1244 |
5/1/2018 |
| Hizentra Immune Globulin Subcutaneous (Human), 20% Liquid |
To include the treatment of adult patients with chronic inflammatory demyelinating polyneuropathy (CIDP) as maintenance therapy to prevent relapse of neuromuscular disability and impairment. | 125350/641 | CSL Behring AG Wankdorfstrasse 10, 3000 Berne 22, Switzerland Lic # 1766 |
3/15/2018 |
| FLUARIX Quadrivalent Influenza Virus Vaccine |
To extend the age range for use of Fluarix Quadrivalent to include children 6 to 35 months of age. | 125127/834 | GlaxoSmithKline Biologicals Rue de l'Institut 89, B1330 Rixensart, Belgium Lic. # 1617 |
1/11/2018 |