There were no new U.S. Veterinary Biologics Establishment Licenses or Permits (new permittees)

issued this quarter.

________________________________________________________________

New U.S. Veterinary Biologics Product Licenses and Biological Product Permits (new codes) were

issued as follows:

________________________________________________________________

There were no U.S. Veterinary Biologics Establishment Licenses or Permits (Permittees) terminated

this quarter.

________________________________________________________________

U.S. Veterinary Biological Product Licenses and Permits (codes) were terminated without prejudice

as follows:

United States Department of Agriculture

Animal and Plant

Health Inspection

Services

Veterinary Services

Center for Veterinary

Biologics

1920 Dayton Ave

PO Box 844

Ames, IA 50010

(515) 337-6100

CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 23-13

TO:

FROM:

SUBJECT:

Biologics Licensees, Permittees, and Applicants

Directors, Center for Veterinary Biologics

Veterinary Services Leadership Team

David M. White

Acting Director

Issuance of Licenses

The purpose of this notice is to bring to the attention of interested parties licenses issued and

terminated between April 01, 2023 and June 30, 2023. These do not include those licenses

reissued to update pertinent information.

True Name Code Est. Name/No.

Avian Influenza-Bursal Disease-Marek's Disease Vaccine, H5 Subtype, Serotype

3, Live Marek's Disease Vector

1L81.R0 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Borrelia Burgdorferi Bacterin 2126.R3 Hennessy Research Associates,

LLC/Est No. 597

Canine Parvovirus Monoclonal Antibody 3415.20 Elanco US Inc./Est No. 196

Clostridium Chauvoei, Killed Culture GA30.00 Zoetis Inc./Est No. 190

Escherichia Coli Bacterial Extract 264E.06 Epitopix, LLC/Est No. 365

Feline Immunodeficiency Virus Antibody Test Kit 5036.00 Biotech Laboratories U.S.A. LLC/Est

No. 671

Feline Leukemia Virus Antigen-Feline Immunodeficiency Virus Antibody Test

Kit

502A.00 Biotech Laboratories U.S.A. LLC/Est

No. 671

Prescription Product, Killed Baculovirus Vector 9PP0.R2 Medgene Labs/Est No. 474

Swine Influenza Vaccine, H3, Killed Baculovirus Vector 19A5.RA Medgene Labs/Est No. 474

True Name Code Est. Name/No.

Avian Adenovirus Vaccine, Killed Virus 1017.00 ARKO Laboratories, Ltd./Est No. 337

An Equal Opportunity Provider and Employer
CENTER FOR VETERINARY BIOLOGICS NOTICE NO. 23-13

Page 2

________________________________________________________________

There were no Product Licenses or Permits (codes) issued due to an acquisition this quarter.

True Name Code Est. Name/No.

Avian Influenza-Marek's Disease Vaccine, H5 Subtype, Serotype 3, Live Marek's

Disease Vector

1062.R2 Ceva Animal Health, LLC/Est No. 368

Canine PD-1 Monoclonal Antibody Cancer Immunotherapeutic 9790.00 Intervet Inc./Est No. 165A

Equine Rhinitis A Vaccine, Killed Virus 1522.21 Boehringer Ingelheim Animal Health

USA Inc./Est No. 124

Escherichia Coli Antibody, Equine Origin 3526.C0 Plasvacc USA, Inc./Est No. 360

Heartworm Antibody Test Kit EF18.00 Diamond Animal Health, Inc./Est No.

213

Heartworm Antibody Test Kit 5F18.00 Diamond Animal Health, Inc./Est No.

213

Mycoplasma Hyopneumoniae Bacterin 2775.03 Zoetis Inc./Est No. 190

Rhodococcus Equi-Streptococcus Equi Antibody, Equine Origin 3751.00 Mg Biologics, Inc./Est No. 614

Rubeola Virus Immunomodulator I400.00 Diamond Animal Health, Inc./Est No.

213

Streptococcus Equi Antibody, Equine Origin 3880.00 Mg Biologics, Inc./Est No. 614

Swine Influenza Vaccine, H1N1 & H3N2, Killed Virus 19A5.29 Zoetis Inc./Est No. 190

Swine Influenza Vaccine, H1N1 & H3N2, Killed Virus, Mycoplasma

Hyopneumoniae Bacterin

4995.26 Zoetis Inc./Est No. 190

West Nile Virus Antibody, Equine Origin 3995.00 Colorado Serum Company/Est No. 188

An Equal Opportunity Provider and Employer