|
 AstraZeneca said it had been issued with a complete response letter
(CRL) from the U.S. Food and Drug Administration for its ZS-9 drug.
Such letters typically outline concerns and conditions that must be
addressed to gain U.S. approval.
The rejection is the second time the FDA has failed to approve the
drug which Astra acquired when it bought ZS Pharma for $2.7 billion
in 2015.
"The CRL followed an inspection by the FDA of the ZS-9 manufacturing
facility," Astra said. "The CRL does not require the generation of
any new clinical data. AstraZeneca and ZS Pharma are committed to
working with the FDA to resolve the remaining matters under review
as soon as possible."
ZS-9 treats hyperkalaemia, or high potassium levels, which is
typically associated with chronic kidney disease and chronic heart
failure.
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(Reporting by Kate Holton; editing by Costas Pitas)
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