Posted by Michael Wonder on 26 Oct 2020
Spectrum Pharmaceuticals announces that the FDA is deferring its action on the BLA for Rolontis (eflapegrastim)
26 October 2020 - Agency cites inability to conduct inspection of the drug substance manufacturing facility due to COVID-19 related travel restrictions.
Spectrum Pharmaceuticals today announced that an inspection of the Hanmi Bioplant in South Korea is required before the FDA can approve the company’s biologics license application for Rolontis. The FDA was unable to conduct an inspection during the current review cycle due to restrictions on travel related to the COVID-19 pandemic.
Therefore, the FDA is deferring action on the application until an inspection can be completed. The company will continue to work actively with the FDA to define an approach for scheduling the required inspection. Spectrum has confirmed with the FDA that this is not a complete response letter.
