The first brand of veterinary levothyroxine sodium to receive FDA approval has created a shake-up in long-standing treatment protocols for hypothyroidism in dogs. Nine out of 10 brands of levothyroxine sodium can no longer be manufactured or distributed due to a federal initiative to lower the number of unapproved animal drugs on the market. Acknowledging this disruption, FDA officials say practitioners with existing stocks of the drugs may continue to prescribe what they have on hand.
Source: VIN News Service, March 10, 2016.
The FDA announced on Jan. 29 that it sent warning letters to Merck Animal Health, Neogen Corporation, Virbac Animal Health, Quality Animal Care Manufacturing, Dechra Veterinary Products and Diamond Animal Health, notifying the companies that their levothyroxine products are not in compliance with the Federal Food, Drug, and Cosmetic Act of 1938 and “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.”
INSIGHTS: Thyro-Tabs® Canine made by Lloyd Inc. is the first and only FDA-approved higher USP standard canine T4 tablet. The products affected by the FDA actions are: Leventa, Levocrine, Soloxine, Thyroid Chewable Tablets, Thyrokare, Thyromed, Thyrosyn, ThyroVet and Thyroxine.