Phibro Animal Health Corporation Submits Studies Reaffirming Safety of Mecadox®

July 12, 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. [Source: Phibro Press Release, July 11, 2016]

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.

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.

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