LONDON and PHILADELPHIA, March 4 /PRNewswire-FirstCall/ -- GlaxoSmithKline
(NYSE: 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.
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 http://www.gsk.com.
SOURCE GlaxoSmithKline
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