YorkieTalk.com Forums - Yorkshire Terrier Community - View Single Post - Thyroid Drugs for dog's, FDA issues warning to makers

TxVicki · 02-01-2016, 04:48 PM

Subject: Fw: FDA warns makers of hypothyroidism drugs used in dogs

FDA Issues Warning Letters to Manufacturers of Unapproved Levothyroxine Drugs for Hypothyroidism in Dogs

FDA Issues Warning Letters to Manufacturers of Unapproved Levothyroxine Drugs
for Hypothyroidism in Dogs

January 29, 2016

The U.S. Food and Drug Administration has issued warning letters to six
manufacturers of unapproved levothyroxine sodium drugs for hypothyroidism in
dogs. These unapproved products have not been reviewed by the FDA for safety
and effectiveness.

Thyro-Tabs Canine (levothyroxine sodium tablets), (NADA 141-448) is the only
FDA-approved drug for replacement therapy for diminished thyroid function
(commonly known as hypothyroidism) in dogs.

FDA is concerned about unapproved animal drugs. Animal drugs that have not
been reviewed and approved by FDA may not meet FDA’s strict standards for
safety and effectiveness. They also may not be properly manufactured or labeled.

FDA issued warning letters to manufacturers of the following unapproved
levothyroxine products:

Thyrosyn
Soloxine
Levocrine
Thyromed
Thyroid Chewable Tablets
Thyrokare
Thyroxine L
Thyrovet
Leventa (letter to be posted soon)

If the companies that were issued the warning letters continue to market the
violative products, they may be subject to enforcement action, including
seizure of violative products and/or an injunction.

Shipments of levothyroxine active pharmaceutical ingredient (API) not
referenced in an approved animal drug application or the subject of an index
listing or a valid investigational use exemption and unapproved finished
animal drugs containing levothyroxine offered for import may be subject to
refusal.

Dog owners and veterinarians can report to the FDA any adverse events,
including ineffectiveness, in dogs that received approved or unapproved
hypothyroidism products. Information on reporting adverse events can be found
at:
How to Report Animal Drug Side Effects and Product Problems.

Warning Letters

Neogen Corporation
Quality Animal Care Manufacturing
Virbac Animal Health, Inc.
Dechra Veterinary Products LLC
Diamond Animal Health Inc.

Additional Information

Dear Veterinarian Letter - THYRO-TABS CANINE (levothyroxine sodium tablets)
More information on FDA’s concerns regarding unapproved animal drugs
Information on how to tell if a drug is FDA-approved for animals
From an Idea to the Marketplace: The Journey of an Animal Drug through
the Approval Process

Contact FDA
240-402-7002
240-276-9115 FAX
Issued by: FDA, Center for Veterinary Medicine

7519 Standish Place, HFV-1
Rockville, MD 20855

__._,_.___

--------------------------------------------------------------------------------

02-01-2016, 04:48 PM	#1
TxVicki Donating YT 500 Club Member Join Date: Dec 2010 Location: At Home Posts: 8,386	Thyroid Drugs for dog's, FDA issues warning to makers Subject: Fw: FDA warns makers of hypothyroidism drugs used in dogs FDA Issues Warning Letters to Manufacturers of Unapproved Levothyroxine Drugs for Hypothyroidism in Dogs FDA Issues Warning Letters to Manufacturers of Unapproved Levothyroxine Drugs for Hypothyroidism in Dogs January 29, 2016 The U.S. Food and Drug Administration has issued warning letters to six manufacturers of unapproved levothyroxine sodium drugs for hypothyroidism in dogs. These unapproved products have not been reviewed by the FDA for safety and effectiveness. Thyro-Tabs Canine (levothyroxine sodium tablets), (NADA 141-448) is the only FDA-approved drug for replacement therapy for diminished thyroid function (commonly known as hypothyroidism) in dogs. FDA is concerned about unapproved animal drugs. Animal drugs that have not been reviewed and approved by FDA may not meet FDA’s strict standards for safety and effectiveness. They also may not be properly manufactured or labeled. FDA issued warning letters to manufacturers of the following unapproved levothyroxine products: Thyrosyn Soloxine Levocrine Thyromed Thyroid Chewable Tablets Thyrokare Thyroxine L Thyrovet Leventa (letter to be posted soon) If the companies that were issued the warning letters continue to market the violative products, they may be subject to enforcement action, including seizure of violative products and/or an injunction. Shipments of levothyroxine active pharmaceutical ingredient (API) not referenced in an approved animal drug application or the subject of an index listing or a valid investigational use exemption and unapproved finished animal drugs containing levothyroxine offered for import may be subject to refusal. Dog owners and veterinarians can report to the FDA any adverse events, including ineffectiveness, in dogs that received approved or unapproved hypothyroidism products. Information on reporting adverse events can be found at: How to Report Animal Drug Side Effects and Product Problems. Warning Letters Neogen Corporation Quality Animal Care Manufacturing Virbac Animal Health, Inc. Dechra Veterinary Products LLC Diamond Animal Health Inc. Additional Information Dear Veterinarian Letter - THYRO-TABS CANINE (levothyroxine sodium tablets) More information on FDA’s concerns regarding unapproved animal drugs Information on how to tell if a drug is FDA-approved for animals From an Idea to the Marketplace: The Journey of an Animal Drug through the Approval Process Contact FDA 240-402-7002 240-276-9115 FAX Issued by: FDA, Center for Veterinary Medicine 7519 Standish Place, HFV-1 Rockville, MD 20855 __._,_.___ -------------------------------------------------------------------------------- __________________ [SIZE="3"VICKI & ALLIE[/SIZE]