FDA bans Teva Animal Health’s veterinary drugs

The US Food and Drug Administration (FDA) prohibited Teva Animal Health Inc., its president, and two principals from its parent company, from manufacturing and distributing adulterated veterinary drugs.

''The FDA will not tolerate the manufacture and distribution of adulterated animal drugs,'' said Michael Chappell, the FDA's acting associate commissioner for regulatory affairs.

Under the terms of the consent decree, Teva Animal Health cannot resume manufacturing and distributing veterinary drugs until they achieve compliance with current Good Manufacturing Practice (cGMP) and obtain the US regulator's approval.

''Good manufacturing practice standards are the backbone of product quality and the instrument on which the FDA relies most heavily for assurance that veterinary drug products are safe and effective,'' said Bernadette Dunham, director of the FDA's Center for Veterinary Medicine.

Teva Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies in the world and is a leading generic pharmaceutical company. The company develops, manufactures and markets generic and innovative human pharmaceuticals and active pharmaceutical ingredients, as well as animal health pharmaceutical products.

Teva Animal Health sells dozens of medicines for dogs, cattle, horses, sheep, swine and cattle including flea and tick shampoos, ear washes and antibiotics. The company also markets the DVM Pharmaceuticals brand-name dermatologic products for animals.