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AZN AstraZeneca PLC

76.28
0.48 (0.63%)
After Hours
Last Updated: 22:49:09
Delayed by 15 minutes
Name Symbol Market Type
AstraZeneca PLC NASDAQ:AZN NASDAQ Depository Receipt
  Price Change % Change Price Bid Price Offer Price High Price Low Price Open Price Traded Last Trade
  0.48 0.63% 76.28 76.27 76.64 76.49 75.43 76.47 9,026,089 22:49:09

AstraZeneca: FDA Requests More Analysis for Approval of Roxadustat

21/12/2020 7:44am

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By Sabela Ojea

 

AstraZeneca PLC said Monday that the U.S. Food and Drug Administration has requested further analysis of clinical data of its Roxadustat drug to complete the review of the new drug application.

The British-Swedish pharmaceutical giant said it will submit along with FibroGen, Inc. additional data to assist with the completion of labeling discussions.

The FTSE-100 listed company added that the new drug application is still under regulatory view, noting that the FDA has set a new action date of March 20, 2021.

The Roxadustat-drug is an oral inhibitor for patients with anemia of chronic kidney disease.

 

Write to Sabela Ojea at sabela.ojea@wsj.com; @sabelaojeaguix

 

(END) Dow Jones Newswires

December 21, 2020 02:29 ET (07:29 GMT)

Copyright (c) 2020 Dow Jones & Company, Inc.

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