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June 23, 2011

Miller, 36 States Reach $40.75 Million Settlementwith GlaxoSmithKline and SB Pharmco

(DES MOINES, Iowa)  Attorney General Tom Miller announced Thursday that he and three dozen other state attorneys general, reached a $40.75 million settlement with GlaxoSmithKline, LLC (GSK) and SB Pharmco Puerto Rico, Inc. (SB Pharmco) arising from alleged substandard drug manufacturing processes.  Iowa’s share of the settlement is $716,570, which will go to Iowa’s Consumer Litigation and Education Fund.

In a petition filed Thursday along with the consent judgment, Miller alleged that GSK and SB Pharmco engaged in unfair and deceptive practices when they manufactured and distributed certain lots of Kytril (a sterile drug used to prevent nausea and vomiting caused by cancer chemotherapy and radiation therapy), Bactroban (an antibiotic ointment used to treat skin infections), Paxil CR (the controlled release formulation of the popular antidepressant drug, Paxil), and Avandamet (a combination Type II diabetes drug) that were adulterated because the manufacturing processes used to produce these lots were substandard.

GSK and SB Pharmco are no longer manufacturing drugs at their Cidra facility, which has been closed since 2009.  As a result of the consent judgment, GSK and SB Pharmco are enjoined from making false, misleading or deceptive claims regarding the manufacturing of all drugs formerly manufactured at the Cidra facility regardless of where these drugs are now produced. In addition, the companies must not misrepresent those drugs’ characteristics, or cause likelihood of confusion or of misunderstanding about the way in which they are manufactured.

Consumers should note that there is no current cause for concern regarding the drugs covered by this agreement because all adulterated batches have been recalled for many years and/or the products’ expiration date is past.  If consumers do have concerns they should contact their health care provider.

Illinois Attorney General Lisa Madigan and Oregon Attorney General John Kroger led the investigation into GSK and SB Pharmco’s manufacturing practices.  Miller and attorneys general of the following states and the District of Columbia participated in the settlement: Alabama, Alaska, Arizona, Arkansas, California, Colorado, Connecticut, Delaware, Florida, Hawaii, Idaho, Kansas, Kentucky, Maine, Maryland, Massachusetts, Michigan, Missouri, Montana, Nebraska, Nevada, New Jersey, North Carolina, North Dakota, Ohio, Pennsylvania, Rhode Island, South Dakota, Tennessee, Texas, Vermont, Washington, West Virginia and Wisconsin.

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