News last update:6 Aug 2012

US FDA approves new in-feed BRD therapy

The US Food and Drug Administration (FDA) has approved Pulmotil, an innovative Bovine Respiratory Disease (BRD) treatment for groups of cattle in the early stages of a BRD outbreak that provides 14 days of sustained in-feed therapy, a practice that reduces stress associated with cattle handling.

Pulmotil is approved for the control of BRD associated with Mannheimia haemolytica, Pasteurella multocida and Histophilus somni in groups of beef and non-lactating dairy cattle, where active BRD has been diagnosed in at least 10% of the animals in the group.
“This approval brings cattle veterinarians and producers a truly new management tool for controlling BRD,” says Jeff Simmons, president, Elanco.
BRD is the most common disease among feedlot cattle, accounting for approximately 75% of feedlot morbidity and 50 – 70% of feedlot deaths costing the industry an estimated $800 to $900 million annually in economic losses due to reduced feed efficiency, treatment costs and deaths.
“As cattle are assessed for BRD, Pulmotil can be fed within the first 45 days after arrival when cattle typically are most susceptible to the disease,” says Jared Gould, technical consultant for Elanco. “By treating with Pulmotil, producers can reduce the number of cattle pulled for individual treatment.”
Additional value
Gould explains that the practice of feeding Pulmotil provides additional value-enhancing benefits. “It’s a good fit for producers who have limited labour resources or where equipment for processing cattle is not easily accessible,” says Gould.
“And with an in-feed therapy, less cattle handling is required, which can reduce stress compared to other treatment options that require more individual animal management.”
Veterinary issue
Similar to the prescription requirement for injectable products, the FDA requires a veterinarian to issue a Veterinary Feed Directive (VFD) for the use of Pulmotil.
The VFD helps ensure veterinarian oversight and judicious use of Pulmotil according to the label use and feeding directions.
The VFD process requires a coordinated effort by the producer, feed-ingredient supplier, veterinarian and nutritionist. Elanco will help facilitate this process through training and ongoing support.
Not global yet
Before making the product widely available, Elanco will conduct additional commercial trials, and work closely with veterinarians and their clients to develop protocols that support the VFD process and maximize Pulmotil’s value in a variety of commercial settings.
Pulmotil (tilmicosin) is to be fed continuously for a single, 14-day period at 568 grams to 757 grams (626 ppm to 834 ppm) per ton of Type C medicated feed as the sole ration to provide 12.5 mg tilmicosin/kg/head/day.

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