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August 3, 2009
By: Jennifer Fiala
For The VIN News Service
Teva Animal Health has stopped manufacturing generics and its DVM
Pharmaceuticals line of products following a crackdown by the U.S. Food
and Drug Administration (FDA) on the company’s quality control
practices.
“We have no additional information to provide at this
time, but will keep our customers apprised of the situation as we have
news to share,” says Denise Bradley, senior director of Teva’s North
America Corporate Communications.
Members of the Veterinary
Information Network (VIN) report that some Teva Animal Health products
are on backorder. The company is commonly known
for its medicated shampoos and skincare products, as well as
supplements.
In an e-mail to the VIN News Service, Bradley adds the following prepared statement:
“Teva
Animal Health regrets the deficiencies in our manufacturing practices,
and we have already initiated corrective actions to ensure that we will
swiftly meet all regulatory requirements. These actions include
conducting a complete analysis of each individual product; retraining
all of our production employees, and revalidating our equipment,
processes and methods.”
Teva’s efforts are in response to a
lawsuit filed by FDA on July 31 in U.S. District Court, suing Teva
Animal Health, as well as the regulatory agency’s move last Friday to
shut down the company’s Missouri plant.
An injunction prohibits the company from manufacturing and distributing
adulterated veterinary drugs.
FDA alleges that three regulatory
inspectors documented “numerous” Good Manufacturing Practice violations.
Other FDA complaints include a
reported failure by the company to establish a quality control unit,
provide adequate employee training, conduct adequate equipment
maintenance and reject drug products that failed to meet quality
specifications.
Teva Animal Health is an arm of Israeli-based
Teva Pharmaceutical Industries Ltd. It was born in January 2006, when
Teva Pharmaceuticals acquired IVAX Corp., its subsidiary, IVX Animal
Health. IVX Animal Health is comprised of Phoenix Science Inc., the
largest manufacturer of generic pharmaceuticals for the U.S.
animal-health market, and DVM Pharmaceuticals, a specialty veterinary
pharmaceutical company focusing on topical dermatologicals and
nutraceuticals for pets, which had merged in 2005 under the IVX Animal
Health name.
“The
FDA will not tolerate the manufacture and distribution of adulterated
animal drugs,” says Michael Chappell, the FDA’s acting associate
commissioner for regulatory affairs, in a news release. “Veterinarians
and pet owners can be assured that the FDA will investigate and take
regulatory actions against companies that produce animal drugs under
conditions and controls that are inadequate to assure their safety and
quality.”
Earlier this month, Teva Pharmaceuticals voluntarily recalled two lots of the anesthetic propofol following a federal
government investigation of recent cases of nonrespiratory febrile
reactions among human patients undergoing endoscopy in the United
States.
Teva’s Bradley insists that the incident is not connected to FDA’s actions against Teva Animal Health.
According
to the lawsuit’s consent decree, future violations will cost the
company $20,000 for each day that Teva fails to comply with any
provision of the decree and an additional $25,000 for each shipment of
veterinary drugs in violation of the decree, up to $7.5 million per
year.
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