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GSK to pay $40.75 mn to 37 US states to settle sub-standard manufacturing lawsuit news
24 June 2011

GlaxoSmithKline Plc (GSK) and SB Pharmco Puerto Rico Inc yesterday agreed to pay $40.75 million to 37 US states and the District of Columbia to settle allegations on selling substandard antidepressants and other medicines produced at its former Puerto Rico factory in the early 2000s.

The 37 states had alleged that GSK and SB Pharmco engaged in unfair and deceptive practices when they manufactured and distributed certain lots of the drugs Kytril, Bactroban, Paxil CR and Avandamet.

The Justice Departments of all these states allege that GSK and SB Pharmco made these drugs from 2001 to 2004, which were manufactured improperly and distributed to vulnerable patients nationwide. The investigation involved instances where certain batches were not sterilised or in other cases medication contained different dosages than indicated on the bottle, among other alleged violations.

The drugs manufactured during this time include, Kytril, used to prevent nausea and vomiting caused by chemotherapy and radiation therapy; Bactroban, an antibiotic ointment for skin infections, Paxil CR, a controlled release formulation of the antidepressant drug, Paxil, and Avandamet, a combination Type II diabetes drug.

Included in the terms of the settlement, GSK and SB Pharmco have been barred from misrepresenting the drugs' characteristics, or causing confusion or misunderstanding about the way in which they are manufactured.

As customary with all pharmaceutical companies operating in the US, GSK, Britain's largest pharmaceutical firm, did not admit to any wrong doing or liability under the US states' consumer protection laws.

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GSK to pay $40.75 mn to 37 US states to settle sub-standard manufacturing lawsuit