FDA approves first generic doramectin topical for cattle

The U.S. Meals and Drug Administration (FDS) has accepted DectoGard, the primary generic doramectin topical resolution for remedy and management of gastrointestinal roundworms, lungworms, eyeworms, grubs, biting and sucking lice, horn flies, and mange mites in cattle.

DectoGard is an antiparasitic drug that comprises the identical energetic ingredient (doramectin topical resolution) in the identical focus and dosage type because the accepted model identify drug product, Dectomax (doramectin topical resolution), which was first accepted to be used in cattle on September 16, 1997. Moreover, information show that residues in meals merchandise derived from cattle handled with DectoGard is not going to signify a public well being concern when the product is used in keeping with the label.

The product labeling instructs individuals dealing with or administering DectoGard to maintain the product away from warmth, sparks, open flame, and different sources of ignition as a result of it’s flammable. The labeling additionally signifies that DectoGard could also be irritating to human pores and skin and eyes, and customers needs to be cautious to not apply it to themselves or to different individuals. Folks dealing with DectoGard ought to put on protecting clothes together with a long-sleeved shirt, protecting gloves, and boots with a water-proof coat when making use of the product. Protecting clothes needs to be washed after use. If unintentional pores and skin contact happens, customers ought to wash the affected space instantly with cleaning soap and water. If unintentional eye publicity happens, customers ought to flush the eyes instantly with water and get medical consideration.

DectoGard is provided in 1 liter, 2.5 liter, and 5 liter multi-dose containers. It’s accessible over-the-counter and is run topically at a dosage of 500 mcg doramectin per kg (227 mcg/lb) of physique weight. Every mL comprises 5 mg of doramectin, ample to deal with 22 lb (10 kg) of physique weight.

DectoGard is sponsored by Aurora Pharmaceutical Inc., based mostly in Northfield, Minnesota.