Glaxo Sees Return for Two Suspended Drugs
GlaxoSmithKline Plc expects to get two withdrawn drugs back on the U.S. market in the middle of this year after signing a legal agreement with regulators over a problem plant in Puerto Rico.
Europe’s biggest drugmaker said on Thursday the early return of Paxil CR and Avandamet, two key products made at the plant, should keep earnings on track to grow at a low double-digit percentage rate at constant currencies in 2005.
News that the problems in Puerto Rico were close to resolution lifted GSK’s stock more than 3 percent.
The so-called consent decree signed with the U.S. Food and Drug Administration (FDA) provides for an independent expert review of processes at the Cidra site to ensure good manufacturing practices.
No fine has been imposed on the company, although there is the potential for future penalties of up to $10 million a year.
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