Tulathromycin Explained

Tulathromycin, sold under the brand name Draxxin among others, is a macrolide antibiotic used to treat bovine respiratory disease in cattle and swine respiratory disease in pigs.[1] [2] [3]

Medical uses

Tulathromycin is indicated for:

Cattle: Treatment and metaphylaxis of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis sensitive to tulathromycin.

Treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis sensitive to tulathromycin.

Pigs: Treatment and metaphylaxis of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Mycoplasma hyopneumoniae, Haemophilus parasuis, and Bordetella bronchiseptica sensitive to tulathromycin.

Sheep: Treatment of the early stages of infectious pododermatitis (foot rot) associated with virulent Dichelobacter nodosus requiring systemic treatment.

Society and culture

Legal status

Tulathromycin (brand name Draxxin) was approved for medical use in the European Union in November 2003.[4]

Tulathromycin (brand names Tulissin and Tulaven) was approved for medical use in the European Union in April 2020.[5] [6]

In July 2020, the Committee for Medicinal Products for Veterinary Use (CVMP) adopted positive opinions, recommending the granting of marketing authorizations for the veterinary medicinal products Increxxa and Tulinovet solutions for injection for cattle, pigs and sheep.[7] [8] The applicant for Increxxa is Elanco GmbH. The applicant for Tulinovet is VMD N.V. Increxxa was approved for veterinary use in the European Union in September 2020.[9]

Brand names

It is marketed by Pfizer Inc. under the brand name Draxxin.

It is marketed by Bimeda Inc. under the brand name Macrosyn, and by Merck & Co. under the brand name Arovyn.[10]

It is also sold under the brand name Increxxa.

Notes and References

  1. Web site: FDA Approves First Generic Tulathromycin Products for Cattle and Swine . U.S. Food and Drug Administration (FDA) . 19 February 2021 . 4 March 2023.
  2. Evans NA . Tulathromycin: an overview of a new triamilide antibiotic for livestock respiratory disease . Veterinary Therapeutics: Research in Applied Veterinary Medicine . 6 . 2 . 83–95 . 2005 . 16094557 .
  3. Villarino N, Brown SA, Martín-Jiménez T . The role of the macrolide tulathromycin in veterinary medicine . Veterinary Journal . London, England . 198 . 2 . 352–7 . November 2013 . 24268476 . 10.1016/j.tvjl.2013.07.032 .
  4. Web site: Draxxin EPAR . European Medicines Agency (EMA) . 17 September 2018 . 20 August 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  5. Web site: Tulissin EPAR . European Medicines Agency (EMA) . 21 February 2020 . 20 August 2020.
  6. Web site: Tulaven EPAR . European Medicines Agency (EMA). 21 February 2020. 20 August 2020.
  7. Web site: Increxxa: Pending EC decision . European Medicines Agency . 17 July 2020 . 17 July 2020 . Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  8. Web site: Tulinovet: Pending EC decision . European Medicines Agency . 17 July 2020 . 17 July 2020. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.
  9. Web site: Increxxa EPAR . European Medicines Agency . 17 July 2020 . 5 March 2023.
  10. Web site: Arovyn . Merck . 5 March 2023.