Hanmi Pharm's 'Poziotinib' FDA Approval Put on Hold
[Asia Economy Reporter Hwang Yoon-joo] Hanmi Pharmaceutical announced on the 25th that the expedited approval of the lung cancer drug 'Poziotinib,' which it directly developed and licensed to Spectrum in the United States, has been delayed.
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Hanmi Pharmaceutical stated, "On December 6, 2021, Spectrum submitted a New Drug Application (NDA) for 'Poziotinib' to the U.S. Food and Drug Administration (FDA), and at this time, we have received a Complete Response Letter (CRL) indicating that Poziotinib cannot be approved."
This content was produced with the assistance of AI translation services.
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