Business
Phibro Animal Health Corporation Welcomes FDA Hearing on Mecadox®
TEANECK, N.J.--(BUSINESS WIRE)-- Phibro Animal Health Corporation (NASDAQ:PAHC): Today, the Food and Drug Administration (FDA) provided notice in the Federal
About this update from Phibro Animal Health Corporation
[{"type":"text","content":" TEANECK, N.J.--(BUSINESS WIRE)--\nPhibro Animal Health Corporation (NASDAQ:PAHC): Today, the Food and Drug Administration (FDA) provided notice in the Federal Register of its intention to hold a public hearing regarding Mecadox® (carbadox). Mecadox has been approved and sold in the United States for 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.\n\nThe hearing will be hosted by the FDA and will take place on March 10, 2022. The Agency will be seeking data and information related to the safety of the product.\n\nIn 2016, the FDA issued a Notice of Opportunity for Hearing (NOOH) setting in motion the initial steps in a process to rescind its approval of carbadox based on concerns about the potential persistence of carcinogenic residues. In 2020, the FDA formally withdrew the NOOH and instead issued a Proposed Order to rescind approval for the “regulatory method” that is part of carbadox’s FDA approval.\n\nFor the past 5+ years, Phibro has continued an ongoing process of responding collaboratively and transparently to FDA’s Center for Veterinary Medicine (CVM) inquiries to provide extensive and meticulous research and data that confirm the safety of carbadox and that no carbadox residues of carcinogenic concern can be detected at the end of the labeled withdrawal period.\n\nWe welcome CVM’s decision to hold this hearing and hope that the Agency will take stakeholder input into consideration, engaging with scientists, swine producers, and others regarding the safety and unique and unparalleled efficacy of carbadox for half a century. We understand FDA has put the 2020 Proposed Order on hold. We are confident that this hearing will affirm and support the continued safe use of carbadox in the market. In the event that following this hearing FDA continues to assert that the carbadox should be removed from the market, Phibro is entitled to and expects to have a full evidentiary hearing on the merits before an administrative law judge.\n\nMecadox (carbadox) continues to be available for use by our customers. Phibro will continue to defend swine producers’ ability to use Mecadox to protect the health and welfare of their animals and is confident that it will be able to reaffirm that the u...