Merck Animal Health has announced “significant progress” in the implementation of its Zilmax Five-Step Plan (follow that link for details). With insights from the company’s advisory board, an extensive assessment and analysis of existing, as well as new product data, was conducted, Merck says.
Merck had suspended sales of Zilmax in August of 2013 following processors refusing cattle fed the feed additive siting health issues in a number of cattle fed the product. (Read more on that, here.)
In developing and implementing its 5 Step Plan, Merck Animal Health obtained the input of industry experts, business partners and customers about the product and its use, the company says. The “totality of the comprehensive review”supported that Zilmax is safe when used according to the product label and in conjunction with sound animal husbandry practices.
The research results and industry data showed that cattle weights, and thus feed consumption rates, have been steadily increasing over time. This created the possibility that certain cattle could consume feed quantities that result in ingestion of Zilmax in an amount that exceeds the approved dose, says Merck. The review also noted that enhanced label language – coupled with the implementation of comprehensive certification requirements and a thorough best practices program – will ensure that usage of Zilmax remains compliant with the label.
The U.S. FDA has also approved updates to the Zilmax label, including a new feed delivery method, however these updates are limited to the U.S. at this time. Merck has recently filed a similar label update submission with the Canadian Veterinary Drug Directorate (VDD) and it is currently under evaluation, the company says.
Click here for the company’s in-depth press release on the topic: Merck Statement November 2014.