nixiFLOR, the first generic version of Resflor GOLD
The U.S. Food and Drug Administration has approved nixiFLOR, an injectable solution combining florfenicol and flunixin meglumine, for the treatment of bovine respiratory disease (BRD) and the control of BRD-associated fever in beef and non-lactating dairy cattle. This approval marks the first FDA-approved generic version of the brand-name product Resflor GOLD.
Bioequivalence established
According to the FDA, nixiFLOR is bioequivalent to the reference listed drug and, when used according to the approved label, does not pose a public health concern related to drug residues in edible tissues. The product includes a 38-day withdrawal period. nixiFLOR is administered via subcutaneous injection in the neck and is limited to a maximum of 10 mL per injection site.
Prescription only
Because accurate diagnosis and oversight are required, nixiFLOR is available by prescription only from a licensed veterinarian. The application for approval was sponsored by Parnell Technologies Pty. Ltd., based in New South Wales, Australia.
Links
Read the FOI summary of nixiFLOR here.
Read the FDA announcement here.