The US Food and Drug Administration (FDA) has issued an order blocking Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) unit Teva Animal Health Inc.
The FDA filed on Friday a consent decree of permanent injunction against Teva unit Teva Animal Health, its president, and two Teva principals from manufacturing and distributing adulterated veterinary drugs. During inspections between 2007 and 2009, the FDA found significant current Good Manufacturing Practice (cGMP) violations at Teva Animal Health's facilities, located in St. Joseph, Missouri.
Under the terms of the consent decree, Teva Animal Health cannot resume manufacturing and distributing veterinary drugs until adequate methods, facilities, and controls are established and an independent expert inspects the facilities and procedures and certifies that they comply with cGMP.
A consent decree is a legal agreement that allows the FDA, or other US government agencies, to enforce a decision without a costly legal process.
According to media reports, Teva spokeswoman Denise Bradley said neither the consent decree nor the halt to animal drugs sales "has any material impact." She said the company does not disclose sales for the animal health unit. Teva "regrets the deficiencies in our manufacturing practices, and we have already initiated corrective actions to ensure that we will swiftly meet all regulatory requirements," she added.
Teva acquired Teva Animal Health through its acquisition of Ivax in 2006. The company develops and manufactures generic veterinary pharmaceutical products. It is the largest US manufacturer of generic pharmaceutical veterinary formulations and its proprietary brand line, DVM Pharmaceuticals, is the industry leader for veterinary dermatological products and nutraceuticals.
Teva's share closed at $53.34 on Nasdaq on Friday. The share rose 0.4% by midday on the TASE today to NIS 202.70.
Published by Globes [online], Israel business news - www.globes-online.com - on August 2, 2009
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