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AstraZeneca PLC said Monday that the United States Food and Drug Administration has requested further analysis of clinical data for its drug Roxadustat to complete the review of the new drug application.
The Anglo-Swedish pharmaceutical giant said it will submit additional data with FibroGen, Inc. to help complete labeling discussions.
The FTSE-100-listed company added that the new drug application was still under regulatory control, noting that the FDA had set a new action date of March 20, 2021.
The drug Roxadustat is an oral inhibitor for patients with chronic renal failure anemia.
Write to Sabela Ojea at [email protected]; @sabelaojeaguix
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