GlaxoSmithKline PLC
04 March 2005
GSK Announces Disruption of Supply for Paxil CR and Avandamet
March 4, 2005 - GlaxoSmithKline (GSK) said today that the US Food and Drug
Administration has halted distribution of supplies of two of its medicines due
to manufacturing issues: Avandamet (rosiglitazone maleate / metformin
hydrochloride) tablets, used to treat type 2 diabetes, and Paxil CR (paroxetine
hydrochloride controlled release) tablets, a treatment for depression and
several anxiety disorders.
The FDA action relates to all strengths of Paxil CR (12.5 mg, 25 mg, and 37.5
mg) as well as Avandamet (1 mg, 2 mg, and 4 mg). In the short term, it is
expected that the FDA action will result in a shortage of patient supplies for
both of these medicines.
GSK believes that the manufacturing issues do not pose a health risk to
patients. GSK agrees with the FDA that patients who use these two medicines
should continue taking their tablets and talk with their healthcare provider if
they have questions.
The company is working with the FDA to resolve these issues as quickly as
possible.
S M Bicknell
Company Secretary
4 March 2005
GlaxoSmithKline - one of the world's leading research-based pharmaceutical and
healthcare companies - is committed to improving the quality of human life by
enabling people to do more, feel better and live longer. For company information
visit www.gsk.com.
________________________________________________________________________________
Enquiries: UK Media Philip Thomson (020) 8047 5502
David Mawdsley (020) 8047 5502
Chris Hunter-Ward (020) 8047 5502
US Media Nancy Pekarek (215) 751 7709
Mary Anne Rhyne (919) 483 2839
Patricia Seif (215) 751 7709
European Analyst / Investor Duncan Learmouth (020) 8047 5540
Anita Kidgell (020) 8047 5542
US Analyst / Investor Frank Murdolo (215) 751 7002
Tom Curry (215) 751 5419
________________________________________________________________________________
This information is provided by RNS
The company news service from the London Stock Exchange
*A Private Investor is a recipient of the information who meets all of the conditions set out below, the recipient:
Obtains access to the information in a personal capacity;
Is not required to be regulated or supervised by a body concerned with the regulation or supervision of investment or financial services;
Is not currently registered or qualified as a professional securities trader or investment adviser with any national or state exchange, regulatory authority, professional association or recognised professional body;
Does not currently act in any capacity as an investment adviser, whether or not they have at some time been qualified to do so;
Uses the information solely in relation to the management of their personal funds and not as a trader to the public or for the investment of corporate funds;
Does not distribute, republish or otherwise provide any information or derived works to any third party in any manner or use or process information or derived works for any commercial purposes.
Please note, this site uses cookies. Some of the cookies are essential for parts of the site to operate and have already been set. You may delete and block all cookies from this site, but if you do, parts of the site may not work. To find out more about the cookies used on Investegate and how you can manage them, see our Privacy and Cookie Policy
To continue using Investegate, please confirm that you are a private investor as well as agreeing to our Privacy and Cookie Policy & Terms.