U.S. FDA issues authorization for first generic animal drug against New World screwworm

LOS ANGELES, June 11 (Xinhua) -- The U.S. Food and Drug Administration (FDA) on Thursday issued an emergency use authorization for a generic animal drug to treat New World screwworm (NWS) infestations in dogs and cats.

The drug, Nitenpyram Tablets (nitenpyram), is the first generic animal drug authorized in the United States for use against NWS, the FDA said. It is for dogs, puppies, cats and kittens weighing at least two pounds and aged four weeks or older.

The FDA concluded that based on the totality of available scientific evidence, it is reasonable to believe that Nitenpyram Tablets may be effective in the treatment of NWS myiasis in certain animals, and that the known and potential benefits outweigh the known and potential risks.

According to the FDA, most dogs and cats in the United States are at low risk of NWS infection, while the risk is higher for pets recently in areas with confirmed cases.

NWS flies lay eggs in the open wounds or mucous membranes of mammals and the larvae hatch within hours and burrow into the animal's flesh. The FDA said nitenpyram acts quickly, killing most larvae within hours after the first dose. A second dose should be administered six hours later.

The agency added that the drug does not prevent NWS myiasis or protect against reinfestation due to its short duration of action.

Nitenpyram Tablets are available over the counter and come in two tablet sizes, 11.4 and 57 mg, with dosage based on the animal's weight, the FDA said.

U.S. Health and Human Services Secretary Robert F. Kennedy Jr. said the authorization is part of efforts to strengthen the national response to the parasite. It provides an affordable and fast-acting treatment for pet owners and supports containment efforts.

The U.S. Department of Agriculture has confirmed nine animal cases of NWS since early June in the states of Texas and New Mexico. Enditem