Tulathromycin

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.

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

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. 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.

Brand names

It is marketed by Zoetis 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.

It is also sold under the brand name Increxxa. by Elanco

References

References

1. (3 August 2022). "Health product highlights 2021: Annexes of products approved in 2021".
2. (17 July 2020). "Tulinovet EPAR".
3. (13 November 2003). "Draxxin PI".
4. (19 February 2021). "FDA Approves First Generic Tulathromycin Products for Cattle and Swine".
5. (2005). "Tulathromycin: an overview of a new triamilide antibiotic for livestock respiratory disease". Veterinary Therapeutics: Research in Applied Veterinary Medicine.
6. (November 2013). "The role of the macrolide tulathromycin in veterinary medicine". Veterinary Journal.
7. (17 September 2018). "Draxxin EPAR".
8. (21 February 2020). "Tulissin EPAR".
9. (21 February 2020). "Tulaven EPAR".
10. (17 July 2020). "Increxxa: Pending EC decision".
11. (17 July 2020). "Tulinovet: Pending EC decision".
12. (17 July 2020). "Increxxa EPAR".
13. "Arovyn". Merck.