Bimeda US launches Macrosyn™ (tulathromycin injection) 100mg, becoming the first available and launched FDA-approved brand alternative Draxxin® in the US.

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Bimeda is pleased to announce the launch of Macrosyn (tulathromycin injection) 100mg. Macrosyn is a ready-to-use injectable solution containing 100 mg of tulathromycin/mL, a broad spectrum, fast-acting antibiotic for use in cattle and swine. Macrosyn is available in 100mL, 250mL, and 500mL sizes.

In gaining approval from the U.S. Food and Drug Administration (FDA), Macrosyn was granted the same label claims as Draxxin and is bioequivalent to the pioneer product in:

• Active ingredient & inactive ingredients (including carriers and excipients)
• Strength, dosage form & route of administration

Additionally, Macrosyn meets the same quality and safety requirements and is manufactured at an approved FDA facility.

Gavin Tierney, CEO, Bimeda, shared his excitement, commenting that:

“Macrosyn is a great addition to Bimeda’s extensive range of products. Our longterm experience in the brand alternative business is proving successful by being the
first to the US market with a brand alternative tulathromycin. We are also proud to
license and manufacture Macrosyn in our new state-of-the-art production line in
North America.”

Macrosyn, the first brand alternative tulathromycin available for the top-selling injectable antibiotic product in the US, is indicated for use to treat specific conditions caused by specific bacteria susceptible to tulathromycin:

• In beef and non-lactating dairy cattle, Macrosyn is approved for the control & treatment of bovine respiratory disease (BRD) (Mannheimia haemolytica, Pasteurella multocida,
Histophilus somni, Mycoplasma bovis), treatment of bovine foot rot (Fusobacterium
necrophorum, Porphyromonas levii), and treatment of pink eye (Moraxella bovis).

• In calves (suckling, dairy and veal calves) Macrosyn is approved for the treatment of
bovine respiratory disease (BRD) (M. haemolytica, P. multocida, H. somni, M. bovis).

• In swine, Macrosyn is approved for the control & treatment of swine respiratory disease
(SRD) (Actinobacillus pleuropneumoniae, P. multocida, Mycoplasma hyopneumoniae), and the treatment of SRD (Haemophilus parasuis, Bordetella bronchiseptica).

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