Vaccines, Blood & Biologics

2015 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.

2015 Biological License Application Approvals
Tradename/
Proper Name
Indication for UseSTNManufacturer/
License Number
Approval Date
VONVENDI
von Willebrand factor (Recombinant)
The proposed indication for von Willebrand factor (Recombinant) is for on-demand treatment and control of bleeding episodes in adults diagnosed with von Willebrand disease (VWD)125577/0Baxalta US Inc.
One Baxter Way,
Westlake Village, CA, 91362

Lic # 2020
12/8/2015
FLUAD
Influenza Vaccine, Adjuvanted
For active immunization of persons 65 years of age and older against influenza disease caused by influenza virus subtypes A and B contained in the vaccine.BLA 125510/0Novartis Vaccines and Diagnostics, Inc.
350 Massachusetts Avenue, Cambridge, MA, 02139

Lic. # 1751
11/24/2015
ADYNOVATE
Antihemophilic Factor (Recombinant), PEGylated
Indicated for adolescent (12 to less than 18 years) and adult (greater than or equal to 18 years) patients with hemophilia A (congenital factor VIII deficiency) for: control and prevention of bleeding episodes and routine prophylaxis to prevent or reduce the frequency of bleeding episodes125566/0Baxalta US Inc.
One Baxter Way, Westlake Village, CA, 91362

Lic. # 2020
11/13/2015
IMLYGIC
Talimogene laherparepvec
for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with melanoma recurrent after initial surgery125518/0Amgen, Inc.
One Amgen Center Drive, Thousand Oaks, CA, 91320-1799

Lic. # 1080
10/27/2015
COAGADEX
Coagulation Factor X (Human)
Treatment of patients with hereditary Factor X Deficiency125506/0Bio Products Laboratory
Dagger Lane, Hertfordshire, WD6 3BX, United Kingdom

Lic. # 1811
10/20/2015
Source PlasmaTo manufacture Source Plasma intended for further manufacture into injectable products using the Haemonetics PCS2 automated collection system,
with the anticoagulant Sodium Citrate Solution, collected from normal, non-immunized donors and utilizing a Physician Substitute program under the provisions of 21 CFR 640.120 at your facility, Hemarus LLC, 11925 Beach Boulevard, Suite 212, Jacksonville, Florida (Registration Number 3007786836).
125367/0Hemarus LLC
11925 Beach Boulevard, Jacksonville, FL, 32246

Lic # 1838
9/11/2015
Nuwiq
Antihemophilic Factor (Recombinant), rAHF
Indicated in adults and children with Hemophilia A for:
• On-demand treatment and control of bleeding episodes
• Perioperative management of bleeding
• Routine prophylaxis to prevent or reduce the frequency of bleeding episodes
125555/0Octapharma Pharmazeutika Produktionsges.m.b.H.
Oberlaaer Strasse 235, Vienna, Austria

Lic. # 1646
9/4/2015
Anavip
Crotalidae Immune F(ab')2 (Equine)
Indicated for management of adult and pediatric patients with North American rattlesnake envenomation.125488/0Instituto Bioclon, S.A. de C.V.
Calzada de Tlalpan 4687, Delegacion Tlalpan, 09, C.P. 14050

Lic # 1900
5/06/2015
RAPLIXA
Fibrin Sealant (Human)
An adjunct to hemostasis in adults undergoing surgery when control of bleeding by standard surgical techniques is ineffective or impractical.125523/0ProFibrix, BV.
Darwinweg 24, Leiden, 2333 CR

Lic # 1994
4/30/2015
IXINITY
Coagulation Factor IX (Recombinant)
Control and prevention of bleeding episodes and peri-operative management in patients with hemophilia B. 125426/0Cangene Corporation
155 Innovation Drive, Winnipeg, Manitoba, R3T5Y3

Lic # 1201
4/29/2015
QUADRACEL
Diphtheria and Tetanus Toxoids and Acellular Pertussis Adsorbed and Inactivated Poliovirus Vaccine
For active immunization against diphtheria, tetanus, pertussis and poliomyelitis in children 4 through 6 years of age.125525/0Sanofi Pasteur Limited
1755 Steeles Avenue West, Toronto, Ontario, M2R 3T4

Lic # 1726
3/24/2015
ANTHRASIL
Anthrax Immune Globulin Intravenous (Human)
Treatment of adult and pediatric patients with toxemia associated with inhalational anthrax.125562/0Cangene Corporation
155 Innovation Drive, Winnipeg, Manitoba, R3T 5Y3

Lic # 1201
3/24/2015
BEXSERO
Meningococcal Group B Vaccine
For active immunization to prevent invasive disease caused by Neisseria meningitidis serogroup B. BEXSERO is approved for use in individuals 10 through 25 years of age.125546/0Novartis Vaccines and Diagnostics, Inc.
350 Massachusetts Avenue, Cambridge, MA 02139

Lic # 1751
1/23/2015

 

Page Last Updated: 01/14/2016
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.