Shares of AstraZeneca plc (ADR) (NYSE: AZN) were trading lower by more than 1.5 percent early Friday after the company confirmed it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration relating to its New Drug Application (NDA) for sodium zirconium cyclosilicate, also known as ZS-9.
ZS-9 is an investigational medicine produced by ZS Pharma, a fully-owned subsidiary AstraZeneca. The medicine is intended for the treatment of hyperkalaemia or high potassium level in the blood serum.
The CRL refers to observations the governmental agency made in a pre-approval manufacturing inspection. However, the letter does not imply that AstraZeneca must submit new clinical data.
"AstraZeneca remains committed to the development of sodium zirconium cyclosilicate as a treatment option for patients with hyperkalaemia," the company said in its press release. "Interactions are ongoing with other health authorities in the European Union and Australia, where sodium zirconium cyclosilicate is currently under separate regulatory review."
Finally, AstraZeneca noted it's working with its subsidiary to evaluate the content of the letter and will also work closely with the FDA to determine the appropriate steps needed for the NDA.
Shares traded recently at $29.49, down 1.54 percent in the pre-market session.
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