FDA will allow Merial to import limited amounts of European version of Immiticide:
Veterinarians asked to be conservative in treating dogs with the drug
More links at the bottom of this post.
Sep 30, 2011
Rockville, Md. — The U.S. Food and Drug Administration (FDA) announced today that it would allow Merial to import limited quanitites of Immiticide from a European supplier to address concerns over a shortage of the drug, which is used to treat heartworm infection in dogs.
FDA says the allowance is temporary while Merial works out technical issues in the plant where Immiticide is manufactured for the United States. Merial’s European supplier, who is the approved source of the product for international markets, has a limited supply for importation which will only satisfy a fraction of the U.S. demand, FDA notes. The agency is asking veterinarians to conserve the limited supply by only using it in dogs in the most urgent need of treatment.
The imported Immiticide will only be available through a restricted distribution program directly from Merial, not through any of its distributors or for purchase to stock clinic inventory, FDA says. The agency notes that the packaging of the imported product is intended for the European market and does not meet U.S. regulatory requirements, so Merial will include the U.S. Immiticide package insert with each shipment.
Shortly after Merial first announced the impending shortage of Immiticide, orders from veterinarians flooded in and cleaned out the company’s stock of the drug, Merial says. The resulting shortage could last for weeks or months, the company says. Since then, Merial says it has recorded requests from veterinarians and, as the limited European supply comes in sometime in October, the company will contact those veterinarians who have made requests.
Additional questions can be directed to Merial at (888) 637-4251.
Also here: http://www.veterinarypracticenews.com/vet-breaking-news/2011/09/30/merial-to-import-limited-quantities-of-immiticide-from-europe.aspx
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. 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.So here is our hope that the neediest cases will receive the treatment that they need and that people will understand the need for, and respect, prioritization.