FDA denies petition on arsenic-based animal drugs

FDA denied a petition to revoke approvals for four arsenic-based additives because makers have requested they be withdrawn or are under FDA review.

On Sept. 30, the Food & Drug Administration denied a petition from the Center for Food Safety and the Institute for Agriculture & Trade Policy that asked the agency to take steps to revoke the approvals of four arsenic-based animal drugs.

FDA said the petitioners’ requests with respect to three of the four drugs at issue became moot after the sponsors of those drugs requested that FDA withdraw the approvals for those products (roxarsone, carbasone and arsinillic acid). With respect to the only remaining approved arsenic-based animal drug (nitarsone), FDA denied the petitioner’s request because the agency is in the process of "completing several scientific studies and reviewing and evaluating information to help the agency more fully evaluate any potential concerns related to the safety of arsenic-based animal drugs."

FDA said it decided to review this information before reaching any conclusions about whether there may be grounds to initiate proceedings to withdraw approval of nitarsone, the only currently marketed arsenic-based animal drug in the U.S. Nitarsone is approved for use in turkeys for the management of blackhead disease.

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