FDA WARNING_LETTER - Novartis Animal Health US Inc - May 04, 2015

The FDA issued a Warning Letter to Novartis Animal Health US, Inc. on May 4, 2015, regarding promotional materials for Denagard (tiamulin hydrogen fumarate) plus CTC (chlortetracycline hydrochloride) medicated feed. The FDA's Center for Veterinary Medicine, Division of Surveillance, reviewed a sell sheet and website materials, finding that they promoted Denagard plus CTC for unapproved new uses, causing the product to be unsafe, adulterated, and misbranded under sections 512, 501(a)(5), and 502(f) of the FD&C Act. Introducing such a drug into interstate commerce violates section 301(a).

Specifically, the promotional materials made economic claims of increased weight gain and feed efficiency, and broadened the approved indications. Denagard plus CTC is only approved for control of swine dysentery associated with *Brachyspira hyodysenteriae* and treatment of swine bacterial enteritis caused by *Escherichia coli* and *Salmonella choleraesuis*, and bacterial pneumonia caused by *Pasteurella multocida*. The promotional claims, such as "improved average daily gain" and "broad-spectrum control of enteric and respiratory diseases," are not supported by the approved labeling. The FDA stated that supporting studies cited by Novartis did not demonstrate that economic benefits resulted from the drug's approved indications, making these claims false or misleading under section