Business
Phibro Animal Health Corporation Reiterates Safety of Mecadox®
TEANECK, N.J.--(BUSINESS WIRE)-- (NASDAQ:PAHC) Today, the Food and Drug Administration (FDA) provided notice of Federal Register publication of its intention
About this update from Phibro Animal Health Corporation
[{"type":"text","content":" TEANECK, N.J.--(BUSINESS WIRE)--\n(NASDAQ:PAHC) Today, the Food and Drug Administration (FDA) provided notice of Federal Register publication of its intention to take a number of actions related to its ongoing review of the regulatory status of Mecadox® (carbadox). Mecadox has been approved and sold in the United States for more than 45 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\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 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 Center for Veterinary Medicine (CVM) inquiries to provide extensive and meticulous research and data that confirm the safety of carbadox.\n\n\nPhibro believes that the evidence submitted to FDA:\n\n\n\nConcludes that no carbadox residues of carcinogenic concern can be detected at the end of the labeled withdrawal period.\n\n\nConfirms that carbadox remains a safe drug to control bacterial diseases in swine.\n\n\nIncreases our collective understanding of the drug’s metabolism, residue characterization and depletion.\n\n\nReinforces and affirms prior FDA determinations that the use of carbadox is safe as approved.\n\n\n\nIn the notice published by the FDA, the agency states it does not agree with Phibro’s scientific conclusions and announced a new process for the review of carbadox, 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. Phibro disagrees with the agency’s conclusions and is disappointed that it is taking these steps. Phibro stands ready to discuss alternative regulatory methods if the FDA believes that the current method is inappropriate.\n\n\nPhibro has requested to the FDA Office of the Commissioner that the agency continue the process it started in 2016 and proceed with a hearing to review the substantial body of data supporting the safety of carbadox. In addition to the science proving the safety of car...