Merck Animal Health Provides Update on Zilmax Five-Step Plan, Announces Next Steps


November 5, 2014 8:30 am ET

Extensive review and analysis of research data completed

Final stage to focus on planned in-field use studies

Best Management Practices and Certification Program adopted

FDA approval of updates to Zilmax label, including new feed delivery method

Merck Animal Health (known outside the United States and Canada as MSD
Animal Health) is pleased to announce significant progress in the
implementation of its Zilmax Five-Step Plan. With insights from the
company’s advisory board, an extensive assessment and analysis of
existing, as well as new product data, was conducted. Additionally,
Merck Animal Health obtained the input of industry experts, business
partners and customers about the product and its use.

The totality of the comprehensive review supported that Zilmax®
(zilpaterol hydrochloride) 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. 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.

An updated Zilmax label, to include Component Feeding, which is an
alternative method of administering Zilmax using a targeted lower dose,
was submitted to and approved by the U.S. Food and Drug Administration
(FDA). Component Feeding provides cattle feeders with an alternative
option to deliver the appropriate dose of Zilmax to cattle every day.
The new convenient feed delivery method allows cattle feeders to mix
Zilmax in feed to deliver a lower targeted dose of 60 mg/head/day of

In addition, to help ensure that use of Zilmax is appropriate and
consistent with best practices, Merck Animal Health has taken the
following steps:


As previously noted, every feedyard team member, distributor, feed
manufacturer, nutritionist and veterinarian who uses Zilmax or provides
consultative services on feeding Zilmax to cattle, must complete the
Zilmax training program, as well as annual retraining, addressing the
proper use of the product. The training will focus on best practices,
product handling, mixing protocols, cattle management, product
inventory, record keeping and clean-out procedures. Completion and
adherence to the program will be a prerequisite for the use of Zilmax. [Certification

Best Management Practices

Merck Animal Health has worked with industry experts to develop
comprehensive Best Management Practices. These include best regimens for
the feeding of Zilmax, as well as a number of factors that are critical
to animal well-being, including animal handling, proper
nutrition/feeding protocols, environmental risk factors, transportation,
and cattle management and selection. [Best
Management Practices Program

“Emphasizing best management practices illustrates our commitment to our
industry partners by helping set benchmarks for animal mobility,
mitigating risk factors, and reinforcing the significant role of
nutrition and handling in animal performance,” said KJ Varma, BVSc,
Ph.D., Diplomate ACVCP, Senior Vice President Global R&D, Merck Animal
Health. “We remain committed to working closely with our customers to
maintain the highest standards of care for the health and well-being of

Planned In-Field Use Studies

Merck Animal Health also maintains its commitment to sound science – a
cornerstone of the Five-Step Plan. The significant advances noted have
enabled the company to move forward with the next step – the In-Field
Use Studies, for which we will seek the participation of industry
partners. Given the addition of Component Feeding to the label, the
planned In-Field Use Study design and protocols will be reviewed before
the studies commence. As previously noted, these studies will be
overseen by an independent third-party and will extend into the high
heat months. The guiding principles of the studies remain the same:

  • Observing cattle throughout the system – before and after receiving
    Zilmax – at the feedyard and at the packing plant;
  • Evaluating the mobility of cattle by trained third-party experts
    utilizing an established mobility scoring system; and
  • Reviewing potential confounding factors, such as nutrition,
    transportation, receiving facilities, flooring surfaces and, cattle
    management and handling practices, given that mobility issues can be
    the result of numerous issues or even multifactorial in nature.

For the duration of the Planned In-Field Use Studies, Zilmax will be
made available only to cattle feeders that can meet and maintain all
conditions of the Best Management Practices initiative and the
Certification Program, as well as fully comply with all protocols of the
In-Field Use Studies. We believe the results of the In-Field Use Studies
will help support the return of Zilmax to the market place in the future.

Additional Label Modifications

In addition to Component Feeding, the FDA has approved a revision to the
existing Complete Feed indication in the label. The current Complete
Feed label dose for zilpaterol is 6.8 grams/ton to provide 60 to 90
mg/head/day. The label will now include an updated caution statement
that notes cattle should not be fed Zilmax in excess of 90 mg/head/day.
If pen consumption of complete feed exceeds 26.5 lb/head/day (90% on a
dry matter basis), zilpaterol should not be fed in complete feed. This
additional language will further ensure that Zilmax use remains
compliant with the label, regardless of the delivery feed method chosen.

“We are pleased to announce the addition of Component Feeding to the
Zilmax label, and are equally excited to note we are moving ahead with
the Five-Step Plan,” said Dr. Varma. “The work supporting Zilmax has
been complex and time intensive, and we appreciate the time and efforts
of the Merck Animal Health Advisory Board, the input and continued
support of our customers, and the FDA for its commitment to science and
advancing animal well-being.”

Merck Animal Health has recently filed a label update submission in
Canada. Click here to view the updated U.S. Zilmax

Zilmax has a withdrawal period of 3 days prior to harvest. Not
for use in animals intended for breeding.
Do not allow horses or
other equines access to feed containing zilpaterol.
Do not use in
veal calves.
Not to be fed to cattle in excess of 90 mg/head/day
in complete feed.
If pen consumption of complete feed exceeds
26.5 lb/head/day (90 percent dry matter basis), zilpaterol should not be
fed in complete feed.
For complete information, refer to the
product label.

About Merck Animal Health

Today’s Merck is a global healthcare leader working to help the world be
well. Merck Animal Health, known as MSD Animal Health outside the United
States and Canada, is the global animal health business unit of Merck.
Through its commitment to the Science of Healthier Animals™, Merck
Animal Health offers veterinarians, farmers, pet owners and governments
one of the widest range of veterinary pharmaceuticals, vaccines and
health management solutions and services. Merck Animal Health is
dedicated to preserving and improving the health, well-being and
performance of animals. It invests extensively in dynamic and
comprehensive R&D resources and a modern, global supply chain. Merck
Animal Health is present in more than 50 countries, while its products
are available in some 150 markets. For more information, visit
or connect with us on LinkedIn
and Twitter at @MerckAH.

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This news release includes “forward-looking statements” within the
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Merck Animal Health
Pam Eisele, 267-305-3558
Kelly Goss, 913-422-6846
Justin Holko, 908-423-5088

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