TEANECK, N.J., July 11, 2016 – Phibro Animal Health Corporation (NASDAQ:PAHC) today submitted to the Food and Drug Administration (FDA) the findings of several new studies confirming the safety of carbadox, which is used to control bacterial diseases in pigs.
The submission is in response to the FDA’s April 12, 2016, Notice of Opportunity for a Hearing (NOOH) regarding the safety of carbadox, the active ingredient in Mecadox®, and supports Phibro’s request for a hearing.
The newly completed studies, performed by scientists from Charles River Laboratories and the University of Edinburgh, utilized well-established scientific methods to extract and analyze carbadox-derived residues far beyond any level previously achieved. During these studies no carcinogenic carbadox-derived residues were detected in meat from animals treated, as directed, with carbadox. Scientists were able to extract and characterize 100 percent of the residues present at the end of the withdrawal period, including those previously categorized as bound and nontoxic, to determine there are no harmful residues present.
“Safety is our number one priority and we take very seriously our obligation to ensure our products contribute to a safe and wholesome food supply, in addition to improved animal health,” said Larry Miller, Chief Operating Officer at Phibro. “The new studies leave no doubt about the safety of carbadox, and its benefits in preventing animal suffering and disease are well-documented. Therefore, we believe allowing it to remain a treatment option is the responsible course. We stand ready to work closely with the FDA and answer any questions.”
Carbadox is not classified as medically important in human medicine, making it a preferred product to treat animal diseases. Withdrawal of carbadox would be contrary to public health objectives regarding responsible antibiotic use because it would likely lead to increased use of alternate animal antibiotics that are classified as medically important for humans.
In a recent survey, veterinarians involved in the health decisions for a majority of the swine in the U.S. expressed concern that removal of carbadox would increase animal suffering and diseases, including Salmonella, swine dysentery and E.coli. The veterinarians estimate that removal of carbadox would lead to the deaths of more than one million pigs per year. The survey can be found at http://goo.gl/1nn7AE and on the Phibro website at http://investors.pahc.com/events.cfm
Carbadox has been safely used in the U.S. for more than 40 years. No harmful residues have ever been found in food when carbadox is used as approved. The new studies went further than ever before to confirm the product’s safety.
Based on the rigorous new studies confirming the safety of carbadox, the product’s animal health benefits, and the fact that it is an antibiotic not important to human medicine, Phibro’s submission encourages the FDA to maintain its approval of the drug. The executive summary of Phibro’s submission can be found at http://goo.gl/2mNyuX and on the Phibro website at http://investors.pahc.com/events.cfm.
About Phibro Animal Health Corporation
Phibro Animal Health Corporation is a diversified global developer, manufacturer and marketer of a broad range of animal health and mineral nutrition products for use in the production of poultry, swine, cattle, dairy and aquaculture. The company reported net sales of $749 million for the fiscal year ended June 30, 2015. For further information, please visit www.pahc.com.