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US FDA: Teva blocked from selling animal drugs
31 Jul 2009 23:20:56 GMT
Source: Reuters
* FDA: Company failed to meet manufacturing standards

* Teva says not material, working to fix problems

* Shares fall slightly after hours (Adds company, FDA comments, shares)

By Lisa Richwine

WASHINGTON, July 31 (Reuters) - Teva Pharmaceuticals' <TEVA.TA> animal health unit will be blocked from selling veterinary drugs until the company fixes manufacturing problems, U.S. regulators said on Friday.

The Food and Drug Administration said it had filed a legally binding consent decree in court that would require Teva Animal Health Inc to undergo inspections and win agency approval before resuming the manufacture and distribution of animal drugs.

The FDA said it found "significant" violations of manufacturing standards during inspections between 2007 and 2009 of Teva facilities in St. Joseph, Missouri.

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 shares fell to $53 in after-hours trading from the earlier close of $53.34 on the New York Stock Exchange.

Teva Animal Health is the largest U.S. manufacturer of generic animal drugs, according to the company's website. It 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.

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," Bradley said.

The actions include analyses of each product, retraining of production employees and revalidating equipment and processes, Bradley said.

Teva could be subject to penalties of up to $7.5 million per year for future violations, the FDA said. (Reporting by Lisa Richwine and Ransdell Pierson; Editing by Carol Bishopric)


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Last updated:Fri Jul 31 23:23:59 2009