March 16, 2012
On September 7, 2011, the U.S. Food and Drug Administration (FDA or Agency) 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.
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. However, because FDA has approved NADA 141-331, the conditions under which the Agency was exercising enforcement discretion no longer exist.