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AstraZeneca gets U.S. approval for gout drug Zurampic

Tue, 22nd Dec 2015 23:16

Dec 22 (Reuters) - U.S. health regulators on Tuesdayapproved AztraZeneca's drug Zurampic to treat acondition associated with gout to be used in combination withanother type of drug that reduces production of uric acid in thebody.

Zurampic, known chemically as lesinurad, works by helpingthe kidneys to excrete uric acid. Gout is a painful form ofarthritis caused by the buildup of too much uric acid in thebody.

"Zurampic provides a new treatment option for the millionsof people who may develop gout over their lifetimes," BadrulChowdhury, head of the Food and Drug Administration's pulmonary,allergy and rheumatology products division, said in a statement.

As a condition of the approval, the FDA said it will requireAstraZeneca to conduct a study to further assess the kidney andheart safety of the medicine.

The drug's label will include a warning alerting health-careprofessionals to the risk of kidney failure with certainunapproved uses, such as with higher-than-approved doses ofZurampic, the agency said. (Reporting by Bill Berkrot; Editing by Alan Crosby)

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