Merial To Import More Immiticide From Europe
Merial Ltd., still dealing with a U.S. shortage of a drug used to treat severe heartworm disease in dogs, will be allowed to continue importing limited amounts of the product from a European supplier.
The U.S. Food and Drug Administration on Tuesday extended its approval of imports of Immiticide (melarsomine dihydrochloride). The European-sourced product is not FDA approved and has a different expiration period compared with the American version.
Signs of severe heartworm disease in dogs include cough, exercise intolerance, difficulty breathing and abnormal lung sounds, among other symptoms, according to the American Heartworm Society.
The shortage, which began in 2011, led Merial to institute a restricted distribution program for Immiticide. No longer available through veterinary product distributors, the drug may be requested from Merial on a case-by-case basis.
"We ask for your cooperation in conserving this limited supply of Immiticide by using it only for dogs in most urgent need of treatment,” the Duluth, Ga., drug giant reported Nov. 1 in a "Dear Doctor” letter.
Technical issues led Merial’s U.S. supplier to suspend production of Immiticide, the only FDA-licensed drug indicated for the treatment of adult heartworms. The unidentified manufacturer in recent months produced a small amount of Immiticide that carries a shorter than normal shelf life.
The manufacturer expects to close the plant for good by year’s end, Merial reported.
The "Dear Doctor” letter stated that Merial was working to find a new manufacturer but that the approval "will take time.”
Imported Immiticide is packaged for use in other countries, the FDA reported. Merial will provide a U.S. package insert that veterinarians are expected to follow in prescribing the drug.