FDA approves generic doramectin topical solution for cattle

The Food and Drug Administration announced Jan. 11 that the agency has approved DectoGard (PDF), 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, first approved for use in cattle in 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.

A cow and two calves covered in horn flies
The Food and Drug Administration has approved DectoGard, a generic doramectin topical solution, for treatment and control of horn flies and several other parasites in cattle.

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

People handling DectoGard should wear protective clothing, including a long-sleeved shirt, protective gloves, and boots with a waterproof coating, 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. The Centers for Disease Control and Prevention’s National Institute for Occupational Safety and Health offers guidance on safe handling of hazardous drugs for veterinary health care workers.

DectoGard is supplied in 1-liter, 2.5-liter, and 5-liter multidose 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.