FDA WARNING_LETTER - ECO LLC, DBA ECO Animal Health - December 23, 2014

The FDA issued a Warning Letter to ECO LLC, DBA ECO Animal Health, and Pharmgate Animal Health, LLC, regarding promotional materials for Aivlosin® (62.5% w/w tylvalosin as tylvalosin tartrate) Water Soluble Granules (WSG). The materials, found on their website and distributed at the 2014 AASV meeting, promote unapproved new uses, rendering Aivlosin® WSG misbranded under section 502(f) and adulterated under section 501(a)(5) of the FD&C Act.

The FDA-approved indication for Aivlosin® WSG is limited to the control of porcine proliferative enteropathy (PPE) associated with Lawsonia intracellularis infection in groups of swine in buildings experiencing an outbreak of PPE, due to its high risk for antimicrobial resistance. The promotional materials omit this crucial "extent of use" limitation and user safety warnings (skin irritation), making them misleading and causing misbranding under 21 U.S.C. §§ 352(a) and 321(n).

Furthermore, the materials make unsubstantiated efficacy claims, suggesting broader use in species (poultry) and conditions (swine dysentery, enzootic pneumonia, Mycoplasma hyopneumoniae eradication) for which Aivlosin® WSG is not approved or lacks scientific data. An unsubstantiated superiority