FDA Approves First Generic Tulathromycin Products for Treating Disease in Certain Cattle and Swine
Source: FDA Center for Veterinary Medicine
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.
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