When drug shortages involve medically necessary veterinary products, it is FDA’s policy to help prevent or alleviate them. FDA works with drug manufacturers in the U.S. and, when necessary, other countries, to find ways to resolve these shortages. FDA does not have the authority to require a company to make any product, even if it is medically necessary.
A Medically Necessary Veterinary Product (MNVP) is a product that: (1) is used to treat or prevent a serious animal disease or condition or is needed to ensure the availability of safe food products of animal origin, and (2) no other available source of that product or adequate alternative drug substitute exists. Owner inconvenience and non-therapeutic uses are inappropriate reasons for classifying a product as an MNVP.
|Date Shortage Began||Drug Product||Sponsor/Manufacturer||Additional Information|
|November 2021||Diroban (melarsomine)||Anzac Animal Health||Component shortage due to supply chain disruption and COVID-19 vaccine demand.|
|August 2021||IMMITICIDE (melarsomine)||Boehringer Ingelheim Animal Health||Capacity constraint with intermittent backorder fulfillment as product becomes available|
|March 2021||R-PEN Soluble Powder (penicillin G potassium)||Huvepharma Inc.||Unavailability of active pharmaceutical ingredient|
|February 2021||PenAqua Sol-G (penicillin G potassium, water soluble)||Bimeda, Inc.||Unavailability of active pharmaceutical ingredient|
|February 2021||Pro-Pen-G (penicillin G procaine, injectable)||Bimeda, Inc.||Unavailability of active pharmaceutical ingredient|
|October 2020||GleptoForte (gleptoferron, 200 mg/ml)||Ceva Sante Animale||Client Information Sheet (imported Gleptosil)
Client information Sheet (imported Ursoferran)
|March 2020||Marquis Antiprotozoal Oral Paste (15% w/w ponazuril)||Boehringer Ingelheim Animal Health||Available on allocation through end of 2022|
|November 13, 2019||Epinephrine 1 mg/mL||Sparhawk Laboratories, Inc.
Customer Service – 800-255-6368
|Increased demands. Approved human product is also available in 30 ml vials.|
|August 8, 2016||Halamid Aqua (chloramine-T)||Axcentive SARL||Manufacturing delay|
|April 13, 2015||IV fluids for animal use, 3L & 5L sizes||Various companies||Demand Increase, reduction in the manufacturing of 3L & 5L sizes|