FDA Approves First Generic Doramectin Topical Solution for Treatment of Certain Parasites in Cattle
January 11, 2023
Today the U.S. Food and Drug Administration approved DectoGard, the first generic doramectin topical solution for treatment and control of gastrointestinal roundworms, lungworms, eyeworms, grubs, biting and sucking lice, horn flies, and mange mites in cattle.
DectoGard is an antiparasitic drug that contains the same active ingredient (doramectin topical solution) in the same concentration and dosage form as the approved brand name drug product, Dectomax (doramectin topical solution), which was first approved for use in cattle on September 16, 1997. Additionally, data demonstrate that residues in food products derived from cattle treated with DectoGard will not represent a public health concern when the product is used according to the label.
The product labeling instructs people handling or administering DectoGard to keep the product away from heat, sparks, open flame, and other sources of ignition because it is flammable. The labeling also indicates that DectoGard may be irritating to human skin and eyes, and users should be careful not to apply it to themselves or to other people. People handling DectoGard should wear protective clothing including a long-sleeved shirt, protective gloves, and boots with a waterproof coat when applying the product. Protective clothing should be washed after use. If accidental skin contact occurs, users should wash the affected area immediately with soap and water. If accidental eye exposure occurs, users should flush the eyes immediately with water and get medical attention.
DectoGard is supplied in 1 liter, 2.5 liter, and 5 liter multi-dose containers. It is available over-the-counter and is administered topically at a dosage of 500 mcg doramectin per kg (227 mcg/lb) of body weight. Each mL contains 5 mg of doramectin, sufficient to treat 22 lb (10 kg) of body weight.
DectoGard is sponsored by Aurora Pharmaceutical, Inc., based in Northfield, Minnesota.
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Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.