Oncology specialist Spectrum Pharmaceuticals (NasdaqGS: SPPI) has announced that the US Food and Drug Administration (FDA) is deferring its action on the company’s Biologics License Application (BLA) for Rolontis (eflapegrastim).
The FDA was unable to conduct an inspection of the Hanmi Bioplant in South Korea during the current review cycle due to restrictions on travel related to the COVID-19 pandemic. This inspection has to be carried out before an approval can be granted. Therefore, the FDA is deferring action on the application until an inspection can be completed.
Spectrum will continue to work actively with the agency to define an approach for scheduling the required inspection. The company has confirmed with the FDA that this is not a Complete Response Letter.
This article is accessible to registered users, to continue reading please register for free. A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.
Login to your accountTry before you buy
7 day trial access
Become a subscriber
Or £77 per month
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed
Chairman, Sanofi Aventis UK
Copyright © The Pharma Letter 2024 | Headless Content Management with Blaze