ROCKVILLE, Maryland, March 16, 2012—On September 7, 2011, the U.S. Food and Drug Administration (FDA) approved a new animal drug application (NADA) for a product containing pergolide mesylate (NADA 141-331) marketed under the trade name Prascend Tablets for the control of the clinical signs associated with Cushing’s Disease in horses. Consistent with this approval, the Agency is announcing that it intends to consider the factors set forth in Compliance Policy Guide (CPG) Sec. 608.400 - Compounding of Drugs for Use in Animals (CPG 7125.40) in evaluating potential enforcement actions involving the compounding of pergolide products for animal use from bulk active pharmaceutical ingredient (API).

In the past, veterinarians prescribed human pergolide products to treat Cushing’s Disease in horses under the “extralabel” use provisions of the Federal Food, Drug, and Cosmetic Act. However, in May 2007, the human pergolide products were removed from the market due to concerns about cardiac side effects in humans. At that time FDA stated that it would work with the sponsors of approved human products and others to ensure that pergolide remained available to treat Cushing’s Syndrome in horses until a new animal drug application was approved for that use. FDA stated that this would include, among other things, exercising enforcement discretion as appropriate over the pharmacy compounding of pergolide for use in animals.

Consistent with our previous statement, based on the approval of Prascend, FDA intends to apply the Federal Food, Drug, and Cosmetic Act requirements regarding new animal drugs to animal drugs containing pergolide that are compounded from bulk API in accordance with CPG 608.400.

Source: U.S. Food and Drug Administration