Someone tell me how they get away with this ****!
GlaxoSmithKline Expects Drugs on Market
04.28.2005, 04:42 AM
Pharmaceutical giant GlaxoSmithKline PLC said Thursday that it expects to have its two withdrawn drugs - anti-depressant Paxil CR and diabetes treatment Avandamet - back on the market by the middle of the year after reaching agreement with U.S. health regulators about problems at its Puerto Rico plant.
Glaxo said that it had agreed to an independent expert review of processes at the Cidra site in Puerto Rico to ensure good manufacturing practice, adding that the return of the drugs to the market should keep earnings on track to grow at a low double-digit percentage rate at constant currencies in 2005.
Glaxo said that no fines had been imposed by the FDA, but acknowledged that it faces penalties of up to US$10 million (euro7.6 million) if the terms of the agreement are not met.
Shares in Glaxo jumped after the drug maker made the announcement in a statement to the London Stock Exchange, rising 2.8 percent to 1,276 pence (US$24.29; euro18.40) in early trade.
Officials from the U.S. Food and Drug Administration seized batches of Paxil CR and Avandamet from a distribution facility in Knoxville, Tennessee, and the Cidra manufacturing facility last month because of manufacturing violations. Paxil CR is designed to treat depression and panic disorder. Avandamet treats Type II diabetes.
Glaxo had earlier recalled certain batches of the two drugs and alerted doctors to the problem, but the failure to recall all of the affected product had led to the federal seizure, the FDA said.
The FDA did not believe the drugs posed significant health risks to consumers, and did not recommend that patients stop taking them. But the FDA wanted to halt the products' distribution until the problems are corrected.
An FDA inspection found Paxil CR tablets could split apart, potentially leaving patients with portions lacking either the active ingredient or the controlled-release effect.
The inspection also found that some Avandamet tablets lacked an accurate dose of one active ingredient.