[lbo-talk] (Wheeee!) care about your health...

Leigh Meyers leighcmeyers at gmail.com
Wed Jun 29 19:59:30 PDT 2005


You'll feel great! You won't care about *anything!*

Just stay away from the Methamphetamines, they're a product of that evil Wyeth pharmeceuticals...

Remember, GlaxoSmithKline... Paxil, good. Wyeth Labs... Methamphetamine, bad.

Thank yew!

http://news.findlaw.com Monday, June 27, 2005

GlaxoSmithKline returns antidepressant Paxil CR to market By DEBORAH YAO AP Business Writer

http://news.findlaw.com/scripts/printer_friendly.pl?page=/ap/o/51/06-28-2005/66c0000bd9df90f5.html

(AP) - PHILADELPHIA-GlaxoSmithKline PLC has returned its antidepressant Paxil CR to market, nearly four months after U.S. officials seized the drug from three facilities for failing to meet manufacturing standards. The pharmaceutical company said Paxil CR tablets now are available in U.S. pharmacies; other markets around the globe will soon stock them as well.

Glaxo said it has identified and fixed the source of the manufacturing problems at its facilities in Knoxville, Tennessee, and Puerto Rico. The improvements were certified by Quantic, a firm approved by the Food and Drug Administration, spokeswoman Nancy Leone said.

Another drug that was seized, Avandamet, will return to distribution within two weeks, the company said. The drug treats Type II diabetes while Paxil treats depression and panic disorder.

"We're very happy that patients formerly treated with Paxil CR will have that treatment option for depression and anxiety symptoms," Leone said Monday.

In March, Food and Drug Administration officials said it seized both drugs from the Tennessee distribution facility and manufacturing and distribution plants in Puerto Rico. At the time, federal regulators said manufacturing practices "failed to meet the standards laid out by the FDA that ensure product safety, strength, quality and purity."

The FDA found that Paxil CR tablets could be split apart, potentially leaving portions without the active ingredient or the controlled-release characteristic. Some Avandamet tables did not have the correct dose of one active ingredient.

While federal regulators did not believe the seized drugs posed a significant threat to patients' health, they wanted to halt distribution until problems could be corrected.

The drugs were seized after an incomplete recall by Glaxo in February.

U.S. shares of U.K.-based Glaxo, whose U.S. headquarters are in Philadelphia and North Carolina, fell 40 cents to close at $48.85 on the New York Stock Exchange.

=30=



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