July 24, 2018
The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) is aware of a shortage of Percorten™-V (desoxycorticosterone pivalate injectable suspension), which is approved for use as replacement therapy for mineralocorticoid deficit in dogs with primary adrenocortical insufficiency, more commonly known as Addison’s Disease.
Dogs with Addison’s Disease have adrenal glands that do not produce enough of two hormones that regulate important health functions. The FDA considers desoxycorticosterone pivalate a medically necessary veterinary drug. When drug shortages involve medically necessary veterinary products, it is the FDA’s policy to work with manufacturers to help ensure there is an adequate supply of products to treat the animals that need them. To this end, the FDA has been in communication with Elanco, the manufacturer of Percorten™-V regarding the shortage situation, which is due to a manufacturing issue with the product. More information from Elanco is available at the Percorten™-V website.
During this shortage situation, the FDA is reminding veterinarians that Zycortal® Suspension, which is also approved for use for the treatment of Canine Addison’s Disease, is an alternative treatment option that is not currently in shortage. Additional information from Zycortal® Suspension’s manufacturer, Dechra, Ltd., can be found on the firm’s website.
Animal drug manufacturers experiencing supply issues that could lead to shortage situations are urged to engage with the FDA’s CVM early by emailing AskCVM@fda.hhs.gov or calling 240-402-7002, so the agency can work to mitigate the impact of the shortage.
- Animal Drug Shortage Information
- NADA 141-029: Percorten-V Suspension
- NADA 141-444: Zycortal Suspension
- Current Animal Drug Shortages
- Resolved Animal Drug Shortages
Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.