FDA Approves ZoaShield 25% for Use in Certain Poultry
September 21, 2020
The FDA’s Center for Veterinary Medicine has approved ZoaShield 25%, the first generic version of zoalene Type A medicated article for the prevention and control of coccidiosis in broiler chickens and growing turkeys and for the development of active immunity to coccidiosis in replacement chickens.
ZoaShield 25% contains the same active ingredient (zoalene Type A medicated article) in the same concentrations and dosage form as the approved brand name drug product, Zoamix, which was first approved in 1960. In addition, the FDA determined that ZoaShield 25% contains no inactive ingredients that may significantly affect the bioavailability of the active ingredients.
The data submitted in support of this Abbreviated New Animal Drug Application demonstrate that ZoaShield 25%, when used according to the label, is safe and effective. Additionally, the data demonstrate that residues in food products derived from broiler chickens, replacement chickens and growing turkeys treated with ZoaShield 25% do not present a public health concern when the product is used according to the label.
ZoaShield 25% is available over-the-counter in 50-pound (22.68 kg) bags.
People handling or administering ZoaShield 25% to poultry should avoid contact with their eyes and avoid inhaling dust.
ZoaShield 25% is sponsored by Pharmasone LLC based in Wilmington, NC.
For more information:
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.