The U.S. Food and Drug Administration has approved the first generic injectable drug that combines florfenicol and flunixin meglumine for use in beef cattle.
The product, nixiFLOR, treats bovine respiratory disease (BRD) and controls BRD-associated fever in beef and non-lactating dairy cattle. It is the first FDA-approved generic equivalent to the brand-name product Resflor GOLD.
New option for BRD management
BRD remains one of the most common and costly health challenges in beef production. The approval of a generic option gives veterinarians and producers another tool to manage respiratory disease and inflammation.
nixiFLOR contains florfenicol, a broad-spectrum antibiotic, and flunixin meglumine, a non-steroidal anti-inflammatory drug. These are the same active ingredients found in the reference product.
The FDA confirmed that nixiFLOR is bioequivalent to the brand-name drug. The agency also determined that tissue residues will not pose a public health risk when producers follow label directions.
Label use and withdrawal period
Producers administer nixiFLOR as a subcutaneous injection in the neck. The labeled dose is 40 mg of florfenicol per kilogram of body weight and 2.2 mg of flunixin per kilogram of body weight, or 6 mL per 100 pounds.
Label directions limit injections to no more than 10 mL per site.
The product carries a 38-day withdrawal period for beef cattle.
nixiFLOR is available by prescription only. A licensed veterinarian must diagnose BRD and oversee treatment to ensure safe and responsible use.
Sponsor and approval details
Parnell Technologies Pty. Ltd. sponsored the application for FDA approval. The company is based in New South Wales, Australia.
Industry experts say the approval supports responsible antimicrobial use while expanding treatment options for beef producers.
For the beef sector, the addition of a generic combination therapy may improve access and flexibility when managing BRD under veterinary guidance.
