FDA Conditionally Approves Drug to Treat New World Screwworm in Dogs

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

The conditional approval means the FDA has determined Credelio Quattro-CA1 is safe and has a reasonable expectation of effectiveness for its intended use. The sponsor, Elanco US Inc. of Indianapolis, Ind., has up to five years to generate the additional effectiveness data needed to support a full FDA approval.

Credelio Quattro-CA1 is eligible for conditional approval because it is intended to treat a serious or life-threatening disease in dogs, it addresses an unmet animal health need, and demonstrating effectiveness of the drug would require complex or particularly difficult studies. Credelio Quattro-CA1 received expedited review through a priority zoonotic animal drug (PZAD) designation, an authority provided to the FDA under the Coronavirus Aid, Relief, and Economic Security (CARES) Act.

Most dogs in the United States are at low risk of NWS exposure due to their geographic location; however, dogs near the U.S.-Mexico border and dogs that have traveled to countries with active NWS infestations are more likely to be exposed to NWS.

Credelio Quattro CA-1 is available in five strengths of flavored chewable tablets. The drug is available only by prescription from a licensed veterinarian because professional expertise is required to monitor for and respond to potential adverse reactions during the course of treatment.

Lotilaner, an active ingredient in Credelio Quattro-CA1, belongs to a class of antiparasitic drugs called isoxazolines. Although isoxazoline products are commonly used and safe for most dogs, the products have been associated with neurologic adverse reactions, including muscle tremors, ataxia, and seizures. Dog owners should consult with a veterinarian to determine whether Credelio Quattro-CA1 is appropriate for their dog.

Credelio Quattro is already fully approved by FDA for various flea, tick, and worm-related indications in dogs and puppies. Credelio Quattro and Credelio Quattro-CA1 contain the same active ingredients, lotilaner, moxidectin, praziquantel, and pyrantel, at the same doses. While each product has a unique application number, the label will contain both Credelio Quattro and Credelio Quattro-CA1 indications.

Short URL: http://caninechronicle.com/?p=346810

Posted by Liz on Dec 22 2025. Filed under Breaking News, Current Articles, Featured. You can follow any responses to this entry through the RSS 2.0. Both comments and pings are currently closed.