The U.S. Food and Drug Administration will allow Merial of Duluth, Ga., to import limited quantities of Immiticide (melarsomine dihydrochloride) from its European supplier.
Immiticide is the only FDA-approved drug to kill adult Dirofilaria immitis, the worm that causes heartworm disease in canines. Merial experienced a technical issue at the plant where the FDA-approved version of the drug is manufactured, and its inventory ran out in August.
Merial said it expects to receive its first shipment of Immiticide from Europe in October and additional shipments on an intermittent basis thereafter. The imported drug is not FDA approved, but is the approved source of the product for international markets.
The imported product can be identified by lot numbers that begin with the letters “MR.” Merial requested that veterinarians record the lot numbers of any imported product they use. The company also requested that veterinarians conserve the limited supply by using it only for dogs in most urgent need of treatment.
The European Immiticide will only be available directly from Merial through a restricted distribution program by calling 1-888-637-4251, option 1. Merial said it has kept records of previous requests and will contact those clinics to complete the order process as appropriate. The European product will not be available through Merial’s distributors or for purchase to stock clinic inventory.
For information on managing heartworm disease during the shortage, please see the previous Veterinary Practice News story here.