US FDA Delays Approval of Hanmi Pharm's 'Rolontis' Due to COVID-19...

[Asia Economy Reporter Geum Boryeong] Hanmi Pharm announced on the 27th that it has received a notification of a provisional delay in the approval of the new drug for neutropenia treatment (Rolontis) from the U.S. Food and Drug Administration (FDA).

Hanmi Pharm's partner, Spectrum, stated, "Due to the U.S. government’s overseas travel restrictions caused by the global spread of the novel coronavirus infection (COVID-19), it was unavoidable that the on-site inspection in Korea (targeting the Pyeongtaek Bio Plant) could not be conducted. Therefore, we received a notification that the approval date for Rolontis, originally scheduled for the 24th, cannot be met and that the approval will be provisionally delayed until the completion of the Korean on-site inspection." They added, "We are actively seeking ways with the FDA to promptly proceed with the Korean on-site inspection."