Diamond Animal Health Inc. 1/27/16
| || |
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
| ||Southwest Region|
Kansas City District
8050 Marshall Drive
Lenexa, Kansas 66214-1524
January 27, 2016
Delivery via UPS
Ref. CMS Case: 444627
Laurie E. Peterson, General Manager
Diamond Animal Health Inc.
2538 SE 43rd Street
Des Moines, IA 50329
Dear Ms. Peterson:
This letter concerns your levothyroxine products for dogs, including Diamond Animal Health, Inc.'s 0.1 mg, 0.2 mg, 0.3 mg, 0.4 mg, 0.5 mg, 0.6 mg, 0.7 mg, and 0.8 mg ThyroMed® chewable tablets. FDA's Center for Veterinary Medicine reviewed product labeling submitted with your drug listing under section 510 of the FD&C Act.
Your levothyroxine products are indicated to provide thyroid replacement therapy in all conditions of inadequate production of thyroid hormones in dogs, which makes them drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) [21 U.S .C. § 321(g)(1)]. In addition, your levothyroxine products are new animal drugs, as defined by section 201(v) of the FD&C Act (21 U.S.C. § 321(v)], because they are not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling.
Your levothyroxine products are not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act [21 U.S.C. §§ 360b, 360ccc, and 360ccc-1]. Therefore, the products are unsafe within the meaning of section 512(a) of the FD&C Act [21 U.S.C. § 360b(a)], and adulterated under section 501(a)(5) of the FD&C Act [21 U.S.C. § 351(a)(5)]. Introduction of an adulterated drug into interstate commerce is prohibited under section 301(a) of the FD&C Act [21 U.S.C. § 331 (a)].
This letter is not intended to be an all-inclusive review of your products. FDA may take enforcement action against these products at any time if they are found to be in violation of the FD&C Act. It is your responsibility to ensure that all of your products are in compliance with the FD&C Act and its implementing regulations.
Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
You should notify this office, in writing, within fifteen (15) working days of the receipt of this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include any documentation necessary to show that correction has been achieved. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.
Please direct your response to the U.S. Food and Drug Administration, Eric Mueller, Compliance Officer, U.S. Food and Drug Administration, 10918 John Galt Blvd., Omaha, NE 68137. If you have any questions about this letter, please contact Compliance Officer Mueller at 402-331-8536 ext 101 or firstname.lastname@example.org
Cheryl A. Bigham
Kansas City District