FDA Approves First Generic Tulathromycin Products for Treating Disease in Certain Cattle and Swine
February 19, 2021
The FDA has approved the first two generic tulathromycin injectable products for the treatment and control of certain diseases in both cattle and swine. Both generic products, Macrosyn and Increxxa, are approved for the following indications:
- treatment of bovine respiratory disease (BRD) associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis in beef and non-lactating dairy cattle, suckling calves, dairy calves and veal calves;
- control of respiratory disease in beef and non-lactating dairy cattle at high risk of developing BRD associated with Mannheimia haemolytica, Pasteurella multocida, Histophilus somni, and Mycoplasma bovis;
- treatment of infectious bovine keratoconjunctivitis (IBK) associated with Moraxella bovis in beef and non-lactating dairy cattle;
- treatment of bovine foot rot (interdigital necrobacillosis) associated with Fusobacterium necrophorum and Porphyromonas levii in beef and non-lactating dairy cattle;
- treatment of swine respiratory disease (SRD) associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, Bordetella bronchiseptica, Haemophilus parasuis, and Mycoplasma hyopneumoniae in pigs; and
- control of SRD associated with Actinobacillus pleuropneumoniae, Pasteurella multocida, and Mycoplasma hyopneumoniae in groups of pigs where SRD has been diagnosed.
Macrosyn and Increxxa contain the same active ingredient (tulathromycin) in the same concentration and dosage form as the approved brand name drug product, Draxxin, which was first approved in 2005. In addition, the FDA determined that Macrosyn and Increxxa contain no inactive ingredients that may significantly affect the bioavailability of the active ingredient.
Tulathromycin is considered an antimicrobial that is important in human medicine and should therefore be used judiciously. Accordingly, like Draxxin, Macrosyn and Increxxa are only available by prescription because a veterinarian’s expertise is required to determine whether tulathromycin is an appropriate therapy and to help guide its judicious use to slow the development of antimicrobial resistance. Additionally, tulathromycin is only approved for use as a single dose. The FDA does not expect that these approvals will increase the overall use of tulathromycin; instead, these generic approvals provide veterinarians with options when prescribing a tulathromycin product.
The data submitted in support of these Abbreviated New Animal Drug Applications demonstrate that Macrosyn and Increxxa, when used according to their labels, are safe and effective. Additionally, the data demonstrate that residues in food products derived from beef cattle, non-lactating dairy cattle, suckling calves, dairy calves, veal calves and swine treated with Macrosyn and Increxxa do not present a public health concern when the products are used according to their labels.
Macrosyn is supplied in 50 mL, 100 mL, 250 mL, and 500 mL vials. Increxxa is available in 100 mL, 250 mL and 500 mL vials.
Macrosyn is sponsored by Bimeda Animal Health Ltd., based in Dublin, Ireland. Increxxa is sponsored by Elanco US Inc., based in Greenfield, Indiana.
For more information:
Freedom of Information Summary - Macrosyn
Freedom of Information Summary - Increxxa
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.