FDA approves generic topical solution for parasites in cattle

The therapy is an antiparasitic drug that contains the same active ingredient as Dectomax.

Officials with the FDA have approved the first generic doramectin topical solution (DectoGard; Aurora Pharmaceutical Inc) for treatment and control of gastrointestinal roundworms, lungworms, eyeworms, grubs, biting and sucking lice, horn flies, and mange mites in cattle.

This therapy 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; Zoetis), 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 doramectin topical solution will not represent a public health concern when the product is used according to the label.

The product labeling instructs people handling or administering doramectin topical solution to keep the product away from heat, sparks, open flame, and other sources of ignition because it is flammable. The labeling also indicates that this therapy may be irritating to human skin and eyes, and users should be careful not to apply it to themselves or to other people.

According to the FDA, people handling doramectin topical solution 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.

Reference

FDA Approves First Generic Doramectin Topical Solution for Treatment of Certain Parasites in Cattle. News release. January 11, 2023. Accessed January 31, 2023. https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-generic-doramectin-topical-solution-treatment-certain-parasites-cattle