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FDA Approves First Generic Florfenicol and Flunixin Meglumine Injection for Bovine Respiratory Disease and Associated Pyrexia in Beef and Non-Lactating Dairy Ca

Jan. 28, 2026

January 22, 2026

The U.S. Food and Drug Administration has approved nixiFLOR (florfenicol and flunixin meglumine) injectable solution for the treatment of bovine respiratory disease (BRD) and control of BRD-associated pyrexia (fever) in beef and non-lactating dairy cattle.

nixiFLOR is the first FDA-approved generic version of Resflor GOLD and contains the same active ingredients (florfenicol, an antibiotic, and flunixin meglumine, a non-steroidal anti-inflammatory) as the approved brand name drug product.

The FDA determined that nixiFLOR injectable solution is bioequivalent to the brand name product, and residues in edible tissues from cattle treated with nixiFLOR will not represent a public health concern when the product is used according to the label, which includes a withdrawal period of 38 days.

nixiFLOR is administered to beef and non-lactating dairy cattle through a subcutaneous injection in the neck at a dose rate of 40 mg florfenicol/kg body weight and 2.2 mg flunixin/kg body weight (6 mL/100 lb). Do not administer more than 10 mL at each site.

nixiFLOR is only available by prescription from a licensed veterinarian because professional expertise is required to accurately diagnose BRD and monitor the safe and effective use of this product.

The application is sponsored by Parnell Technologies Pty. Ltd. based in New South Wales, Australia.

Source from FDA:https://www.fda.gov/animal-veterinary/cvm-updates/fda-approves-first-generic-florfenicol-and-flunixin-meglumine-injection-bovine-respiratory-disease

FDA Approves First Generic Florfenicol and Flunixin Meglumine Injection for Bovine Respiratory Disease and Associated Pyrexia in Beef and Non-Lactating Dairy Cattle

intramammary syringe

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