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Merial, FDA work out system to ease shortage of heartworm treatment
Duluth, Ga. -- Merial and the Food and Drug Administration (FDA) have worked out a new system to ease the shortage of its heartworm treatment Immiticide, the company reports.
Duluth, Ga.
-- Merial and the Food and Drug Administration (FDA) have worked out a new system to ease the shortage of its heartworm treatment Immiticide.
Earlier this year, the company announced a shortage of the drug was imminent because the only U.S. supplier of the active ingredient, melarsomine dihydrochloride, stopped producing the compound. Merial has since identified an alternate supplier of melarsomine, according to Merial's Natasha Joseph Mahanes. But it will take time to ramp up production, and the new supplier will need to gain regulatory approval through FDA, she explains.
In the interim, Merial and FDA's Center for Veterinary Medicine (CVM) have set up an alternate system to triage product requests from veterinarians.
Veterinarians with an immediate need to treat a dog with heartworm infection should direct all inquiries to Merial.
The product will not be available through Merial's distributors, nor will it be available for purchase to stock clinic inventories, the company reports.
"Merial is continuing to work closely with FDA-CVM and the new melarsomine supplier to gain FDA approval for this alternate facility and return to full supply of Immiticide as soon as possible," Joseph Mahanes says in a prepared statement.
For inquires, veterinarians should call Merial Technical Solutions at 1-888-MERIAL1 (1-888-637-4251), Option 1.
