FDA Announces Availability of a Limited Supply of Immiticide
Heartworm Drug Would only Be for Dogs in Urgent Need of Treatment
September 30, 2011
The Food and Drug Administration (FDA) announced today a plan to address concerns regarding the supply of Merial’s Immiticide (melarsomine dihydrochloride), a product used to treat heartworm infection in dogs. FDA is allowing Merial to import limited quantities of Immiticide from their European supplier, which is the approved source of the product for international markets. The measure is temporary, while Merial works out technical issues in the plant where Immiticide is manufactured for use in the U.S.
The European supplier has a limited amount of Immiticide available for importation – a quantity that will only satisfy a fraction of U.S. demand. As a result, veterinarians are being asked for their cooperation to conserve this limited supply by using it only for dogs in most urgent need of treatment.
The product will only be available directly from Merial through a restricted distribution program and will not be available through Merial’s distributors or for purchase to stock clinic inventory. In addition, the packaging of the imported product is in a format intended for other countries and does not meet U.S. regulatory requirements. Therefore, Merial will provide a copy of the U.S. Immiticide Package Insert with each shipment and asks that veterinarians follow the prescribing information it provides.
Additional details on Merial’s temporary measure to import Immiticide can be found in their Dear Doctor letter to veterinarians.
For questions on how to obtain Immiticide, please contact Merial Customer Care at 1-888-MERIAL-1 (1-888-637-4251).