Phibro Animal Health Corporation Reiterates Safety of Mecadox® and Intent to Defend its Use for Customers
07 Novembro 2023 - 12:23PM
Business Wire
(NASDAQ: PAHC) The Food and Drug Administration (FDA), through
its Center for Veterinary Medicine (CVM), has taken two actions
regarding Mecadox® (carbadox), a drug marketed by Phibro Animal
Health Corporation.
In the first action, FDA has provided notice of a Federal
Register publication issuing a final order to revoke the approved
method for detecting residues of carbadox. FDA has also provided
notice of a second Federal Register publication proposing to
withdraw approval of all new animal drug applications (NADAs)
providing for use of carbadox in medicated swine feed and
announcing an opportunity for Phibro to request a hearing on this
proposal. This second action is based on CVM’s determination that
there is no approved regulatory method to detect carbadox residues
in the edible tissues of the treated swine.
Phibro is extremely disappointed in the actions taken by the FDA
and believes fully in the safety of Mecadox. Mecadox (carbadox) has
been approved and sold in the United States for more than 50 years
and is a widely used treatment for controlling bacterial diseases
in swine, including Salmonella and swine dysentery, resulting in
improved health and welfare for newly born and young pigs.
Today’s steps are the latest in a long history of attempted
measures taken by the FDA relating to carbadox that we do not
believe are based on solid science. In 2016, the FDA set in motion
the initial steps in a process to rescind its approval of carbadox
based on its stated concerns about the persistence of carcinogenic
residues. Phibro requested a hearing, and over the next four years
continued an ongoing process of responding collaboratively and
transparently to FDA’s inquiries to provide extensive and
meticulous research and data confirming the safety of carbadox. In
July 2020, FDA voluntarily dismissed the 2016 proceeding and
initiated a new process for review of the carbadox regulatory
method, instead of following its own procedure and moving forward
with a hearing that would resolve the parties’ differing
interpretations of the science supporting the safety of carbadox.
While Phibro has continuously offered to meet with FDA to discuss
the regulatory method and has offered viable alternative methods
currently being used in other countries, it is clear that, instead,
the FDA is ignoring the long history of safety that Phibro has
established and reaffirmed through its most recent studies. As the
FDA publicly stated, going after the regulatory method “is the most
straightforward and least resource-intensive process for removing
carbadox from the market.”
Phibro believes carbadox’s 50+ year history of safe use and
unparalleled therapeutic efficacy, which has significant animal
health and welfare implications, supports its continued use. Phibro
will take appropriate action and next steps to continue to defend
swine producers’ ability to use Mecadox to protect the health and
welfare of their animals.
About Phibro Animal Health Corporation
Phibro Animal Health Corporation is a leading global diversified
animal health and nutrition company. We strive to be a trusted
partner with livestock producers, farmers, veterinarians and
consumers who raise or care for farm and companion animals by
providing solutions to help them maintain and enhance the health of
their animals. For further information, please visit
www.pahc.com.
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version on businesswire.com: https://www.businesswire.com/news/home/20231107525668/en/
Richard Johnson Chief Financial Officer, Phibro Animal Health
Corporation +1 201-329-7300 or investor.relations@pahc.com
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