LONDON, May 27 (Reuters) - AstraZeneca said onFriday U.S. regulators would not approve its new drug for highpotassium levels at present due to a manufacturing issue,dealing a blow to a product acquired when it bought ZS Pharmafor $2.7 billion last year.
The British drugmaker said the Food and Drug Administration(FDA) had issued a so-called complete response letter (CRL) forZS-9, or sodium zirconium cyclosilicate.
Such letters typically outline concerns and conditions thatmust be addressed to gain U.S. approval.
"The CRL refers to observations arising from a pre-approvalmanufacturing inspection," AstraZeneca said. "The FDA alsoacknowledged receipt of recently submitted data which it has yetto review. The CRL does not require the generation of newclinical data."
A spokesman said the company hoped to resolve the matter ina "timely" manner. (Reporting by Ben Hirschler; Editing by Alexander Smith)
Astrazeneca (AZN)
