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FDA Approves VFD Therapy for Cattle BRD

The Food & Drug Administration has approved its Pulmotil (tilmicosin) as a treatment for groups of cattle in the early stages of a bovine respiratory disease (BRD) outbreak to provide 14 days of "sustained in-feed therapy, a practice that reduces stress associated with cattle handling," according to an announcement from Elanco Animal Health.

Elanco said 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.

Similar to the prescription requirement for injectable products, FDA requires a veterinarian to issue a veterinary feed directive (VFD) for the use of Pulmotil. VFDs help ensure veterinarian oversight and judicious use of Pulmotil according to the label use and feeding directions, the announcement said, noting that 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.

Before making the product widely available, Elanco said it 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.

Source: Feedstuffs December 1, 2011