FDA Approves First Generic Drug for Control of Clinical Signs of Equine Cushing’s Disease

The U.S. Food and Drug Administration has approved Zygolide (pergolide tablets) for the control of clinical signs associated with Pituitary Pars Intermedia Dysfunction (PPID) in horses. PPID is also known as Equine Cushing’s Disease, an endocrine condition affecting the pituitary gland of horses.

Zygolide contains the same active ingredient (pergolide) as the approved brand name drug product, Prascend, which was first approved in 2011. The FDA determined that Zygolide tablets are bioequivalent to the brand name product.

Zygolide is available only by prescription from a licensed veterinarian. It has been reported that pergolide tablets may cause eye irritation, an irritating smell or headache when pergolide tablets are split or crushed. Zygolide tablets should not be crushed due to the potential for increased human exposure. People who have had adverse reactions to ergotamine or other ergot derivatives should not administer Zygolide. Like other ergot derivatives, human exposure to pergolide may cause vomiting, dizziness, lethargy or low blood pressure.