August 21, 2012

FDA approves Elanco's Pulmotil^® (tilmicosin), Rumensin^® feeding combination 
 

Press release

The US Food and Drug Administration (FDA) has approved the combination feeding of Pulmotil^®, an in-feed bovine respiratory disease (BRD) treatment, with Rumensin^®, an efficiency-enhancing feed additive.

"Implementing these products together will give producers more options and allow them to feed one ration that contains both Rumensin and Pulmotil," said Carl Guthrie, DVM and Elanco beef technical director.

Approved by the FDA in late 2011, Pulmotil is a BRD treatment for groups of beef and non-lactating dairy cattle in the early stages of an outbreak that provides 14 days of sustained in-feed therapy, a practice that reduces stress associated with cattle handling.

Pulmotil expands BRD control beyond the chute by providing another option for groups of cattle not requiring a metaphylaxis treatment on arrival and/or when labour resources are limited. By feeding Pulmotil, producers can reduce pulls, while requiring less individual animal management.

Rumensin is an efficiency-enhancing feed additive fed to cattle in confinement for slaughter to improve feed efficiency and for the prevention and control of coccidiosis.

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 to ensure veterinarian oversight and judicious use of Pulmotil according to the labelled use and feeding directions. The VFD process requires a coordinated effort by the veterinarian, producer, feed advisor and feed supplier.

Elanco has developed a number of tools to help producers and their veterinarians implement a VFD. Step-by-step directions on how to fill a VFD form, including the combination approval section.

Elanco, a division of Eli Lilly and Company, is a global innovation-driven company that develops and markets products to improve animal health and food animal production in more than 75 countries.