![]() ![]() It is not effective against anaerobic bacteria and may be variable against Streptococcus infections. Increxxa is sponsored by Elanco US Inc., based in Greenfield, Indiana.Enrofloxacin is a broad spectrum bactericidal antibiotic, effective against both Gram-positive and Gram-negative bacteria. ![]() Macrosyn is sponsored by Bimeda Animal Health Ltd., based in Dublin, Ireland. Increxxa is available in 100 mL, 250 mL and 500 mL vials. Macrosyn is supplied in 50 mL, 100 mL, 250 mL, and 500 mL vials. 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. 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. 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. Additionally, tulathromycin is only approved for use as a single dose. 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. ![]() Tulathromycin is considered an antimicrobial that is important in human medicine and should therefore be used judiciously. In addition, the FDA determined that Macrosyn and Increxxa contain no inactive ingredients that may significantly affect the bioavailability of the active ingredient. 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.
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