FDA Revokes Approval of Three Arsenic-Based Animal Drugs

On September 30, the Food and Drug Administration withdrew approvals for three of four animal drugs that contain arsenic. The revocation came after the companies that market the products asked the FDA to withdraw their approval. The FDA denied a Citizen Petition to remove the four arsenic-based animal drugs from the market because the issue became moot after the sponsoring companies requested the removal of three of the drugs in question. The FDA is in the process of completing several scientific studies to help the agency better understand the potential concerns related to the safety of arsenic-based drugs. After these studies, the FDA states that it will initiate proceedings to withdraw the approval of the only remaining arsenic-based animal drug on the market, nitarsone, if there are grounds for its removal.

The arsenic-based drugs that were removed are:
 -  Roxarsone
 -  Arsanilic acid
-  Carbarsone

For more information, please see the FDA Citizen Petition Response.

Written by Sarah L. Doyle - Research Assistant

The Agricultural Law Resource and Reference Center

@PSUAgLawCenter

October 3, 2013