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EU Approves Onglyza Diabetes Drug for Kidney Cases

By Pharmaceutical Processing | March 4, 2011

LONDON (AP) — AstraZeneca PLC and Bristol-Myers Squibb Co.
say their diabetes drug Onglyza has been approved in Europe for treating people
with Type 2 diabetes who have moderate or severe renal impairment.

The two companies said Friday that the approval from the
European Commission makes Onglyza the first so-called DPP4 drug cleared for
such purposes in Europe.

For its regular use, Onglyza has been submitted for
regulatory review in almost 90 countries and is approved in 56 countries,
including the United States,
Canada, Chile, India,
Brazil
and 30 European countries.

The companies last month announced they were expanding the
label of the drug in the United
States to add information about its effects
in patients with kidney failure after receiving approval from the Food and Drug
Administration.

 

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