GlaxoSmithKline [GSK:NYSE] said 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. 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 gsk.

Enquiries:

UK Media
Philip Thomson
David Mawdsley
Chris Hunter-Ward
(020) 8047 5502
(020) 8047 5502
(020) 8047 5502

US Media
Nancy Pekarek
Mary Anne Rhyne
Patricia Seif
(215) 751 7709
(919) 483 2839
(215) 751 7709

European Analyst / Investor
Duncan Learmouth
Anita Kidgell
(020) 8047 5540
(020) 8047 5542
US Analyst / Investor
Frank Murdolo Tom Curry
(215) 751 7002
(215) 751 5419

View drug information on Avandamet; Paxil CR.