Ingelheim, Germany – Boehringer Ingelheim, a global leader in animal health, announces today that the European Commission has issued an extension to the marketing authorisation for Zactran™ for the treatment of infectious pododermatitis (Foot rot) in sheep associated with virulent Dichelobacter nodosus and Fusobacterium necrophorum requiring systemic treatment. This new indication adds to the product’s existing claims for the treatment of respiratory disease in both cattle and swine.

The approval was based on data from a multi-centre field trial including more than 360 sheep on farms across the EU. The trial evaluated the efficacy and safety of a single subcutaneous dose of gamithromycin to treat Foot rot. This trial demonstrated a statistically superior reduction in lameness and a numerically higher reduction in foot lesions versus tilmicosin. On day 21, 97.8% of ZACTRAN-treated sheep achieved treatment success, compared to 93.3% of animals treated with tilmicosin.

Steve Williams, Global Head of Boehringer Ingelheim Strategic Business Unit Ruminants said:
“Boehringer Ingelheim is continually investing in research and development for ruminants and we are pleased to offer veterinarians and farmers Zactran (gamithromycin) for sheep, with a new Foot rot licence extension in the EU. Zactran has a fast action and a broad spectrum of activity against both microorganisms that cause this important condition that affects the welfare and economics of sheep farming in the EU. Used responsibly we believe Zactran will provide a significant benefit to sheep, farmers and veterinarians in treating Foot rot.”

ZACTRAN is available in the EU as a 150 mg/ml solution presented in 50 ml, 150 ml and 250 ml bottles.

For further product information, please visit:
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/veterinary/medicines/000129/vet_med_000198.jsp&mid=WC0b01ac058008d7a8

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