FDA conditionally approves drug for New World screwworm infestation in dogs

The U.S. Food and Drug Administration (FDA) conditionally approves Credelio Quattro-CA1 for treating New World screwworm (NWS) infestations in young dogs and puppies.

The U.S. Food and Drug Administration (FDA) has conditionally approved Credelio Quattro-CA1 (lotilaner, moxidectin, praziquantel, pyrantel) chewable tablets for the treatment of infestations caused by New World screwworm (NWS) larvae, or myiasis, in dogs and puppies at least eight weeks of age and weighing at least 3.3 pounds.

A puppy and two adult mongrel dogs together form the four-legged three musketeers. The three dogs run playing together along a path.

Under conditional approval, the FDA has determined the drug is safe and shows a reasonable expectation of effectiveness for its intended use. The sponsor, Elanco US Inc., has up to five years to submit additional effectiveness data to support full approval. The product qualified for conditional approval because it targets a serious disease, addresses an unmet animal health need, and would require complex studies to demonstrate effectiveness. It also received expedited review through the FDA's priority zoonotic animal drug designation.

While most U.S. dogs face low NWS risk, exposure is higher near the U.S.-Mexico border and in dogs that have traveled to affected regions. Credelio Quattro-CA1 is available by veterinary prescription only.

For more information, visit the Elanco website.

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