FDA Approves First Generic Florfenicol and Flunixin Injection

FDA CVM Veterinary Medicine Updates

Published January 22nd, 2026

Detected March 12th, 2026

Summary

The FDA has approved nixiFLOR, the first generic version of florfenicol and flunixin meglumine injection for treating bovine respiratory disease. This approval marks a new generic option for beef and non-lactating dairy cattle, with a withdrawal period of 38 days.

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What changed

The U.S. Food and Drug Administration (FDA) has approved nixiFLOR, a generic injectable solution containing florfenicol and flunixin meglumine, for the treatment of bovine respiratory disease (BRD) and associated fever in beef and non-lactating dairy cattle. This marks the first generic approval for this combination therapy, which is bioequivalent to the brand-name product Resflor GOLD. The FDA determined that residues from nixiFLOR will not pose a public health concern when used according to the label, which includes a 38-day withdrawal period.

This approval provides a new generic treatment option for veterinarians and cattle producers. While the product is available by prescription only, requiring veterinary expertise for diagnosis and monitoring, its availability may offer cost savings. The application was sponsored by Parnell Technologies Pty. Ltd. of Australia. No specific compliance actions are required for regulated entities beyond adhering to the prescribed veterinary use and withdrawal periods.

Source document (simplified)

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.