| Rolontis, a new neutropenia treatment developed by Hanmi Pharmaceutical, received a notice of reinspection related to production from the US FDA. /Provided by Hanmi Pharm |
Spectrum: “Ask the FDA for further explanation, we will find a solution”
[더팩트ㅣ장병문 기자] Spectrum, a partner of Hanmi Pharm, announced on the 6th (local time) that the US Food and Drug Administration (FDA) was notified that a re-inspection was necessary because there were supplementary provisions in the inspection related to the production of ‘Rolontis’, a new drug for neutropenia.
Spectrum will request further clarification from the FDA, and will hold a meeting with the FDA as soon as possible.
Joe Turgeon, President of Spectrum, said, “We are very sorry about these results, but we look forward to meeting with the FDA to finalize a resolution and timeline,” said Joe Turgeon, President of Spectrum. We plan to fully implement it,” he said.
Neutrophils are the cells that make up the largest proportion of white blood cells. Neutropenia refers to an abnormal decrease in the number of neutrophils in the blood. Rolontis is a long-acting biologic drug administered for the treatment or prevention of neutropenia occurring in cancer patients undergoing chemotherapy.
jangbm@tf.co.kr
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