The US Food and Drug Administration (FDA) has warned Elanco Animal Health that the claims it makes about Reconcile (fluoxetine hydrochloride), its canine separation anxiety treatment, are misleading. Reconcile is the first product of Elanco's Lilly Companion Animal Health division, which was launched earlier this year (Animal Pharm No 605, p 1). The FDA issued a warning letter in late June addressed to Elanco regulatory associate Margaret Gillis and signed by Dr Lynn O Post, director of the Division of Surveillance at the FDA's Center for Veterinary Medicine (CVM). Dr Post said that the CVM had reviewed claims that Elanco had made about the benefits of Reconcile in various articles, consumer brochures, advertisements, and on the Reconcile website, and the CVM had determined that the drug had been misbranded. "These pieces and the product website suggest that the product is more effective than has been demonstrated," Dr Post wrote. Among the statements called into question are Elanco's claim that "73% of dogs receiving Reconcile showed significant improvement within eight weeks compared to placebo-treated animals" and that "42% of dogs receiving Reconcile showed significant improvement within one week compared to placebo-treated animals". Dr Post said: "The above-quoted statements fail to disclose that the dogs in the comparison group were treated with behavior modification and did not just receive a placebo....
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