paxilprogress

paxilprogress (https://www.paxilprogress.org/forums/index.php)
-   News / Research / Articles / Books (https://www.paxilprogress.org/forums/forumdisplay.php?f=15)
-   -   Paxil CR back on market for June/July (https://www.paxilprogress.org/forums/showthread.php?t=11068)

rdjanis 04-28-2005 08:33 PM

Paxil CR back on market for June/July
 
Someone tell me how they get away with this ****!

http://www.forbes.com/business/feeds...ap1982234.html

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Pharmaceutical giant GlaxoSmithKline PLC said Thursday that it expects to have its two withdrawn drugs - anti-depressant Paxil CR and diabetes treatment Avandamet - back on the market by the middle of the year after reaching agreement with U.S. health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.

elisa 04-29-2005 03:01 AM

Re: Paxil CR back on market for June/July
 
Yes it will be a disappointment Rita. But if the manufacturing problems have been solved and the FDA agrees, what can we do about it???

dosalf 05-02-2005 04:46 PM

Re: Paxil CR back on market for June/July
 
That is just a PR effort to calm down shareholders. I work in the industry and the word around is that in fact will be back by June/July but 2006.

It is up to us, the victims to stop Doctors and implode a wave of awareness to the general public.

elisa 05-02-2005 05:32 PM

Re: Paxil CR back on market for June/July
 
Quote:

Originally Posted by dosalf
That is just a PR effort to calm down shareholders. I work in the industry and the word around is that in fact will be back by June/July but 2006.

Let's hope that the "word around" the return of Paxil CR will be in 2006.

angels 05-02-2005 07:49 PM

Re: Paxil CR back on market for June/July
 
Quote:

Originally Posted by dosalf
It is up to us, the victims to stop Doctors and implode a wave of awareness to the general public.

How?

dosalf 05-03-2005 04:03 AM

Re: Paxil CR back on market for June/July
 
That is a good question... It's David vs Golliath, just like the tobacco companies. Maybe demand that the effects (including withdrawal) are visibly posted on the bottle and not burried in a piece of paper which requires a Phd tp figure out. I am sure this drug has affected enuogh people to at least look at it. The problem is not how the medication is produced, the problem is the medication itself

rdjanis 05-03-2005 07:05 AM

Re: Paxil CR back on market for June/July
 
Awareness is a slow process... I think it is starting to happen.

RR 05-03-2005 07:58 AM

Re: Paxil CR back on market for June/July
 
Quote:

Originally Posted by elisa
Let's hope that the "word around" the return of Paxil CR will be in 2006.

Let's hope it's NEVER....

angels 05-03-2005 09:26 AM

Re: Paxil CR back on market for June/July
 
Quote:

Originally Posted by Rob Robinson
Let's hope it's NEVER....

I am already salivating about your book, Rob. Is it done yet?


All times are GMT -6. The time now is 02:56 PM.

Powered by vBulletin® Version 3.6.5
Copyright ©2000 - 2014, Jelsoft Enterprises Ltd.