- As expected, Zosano Pharma (NASDAQ:ZSAN) has received a Complete Response Letter (CRL) from the FDA regarding its marketing application for Qtrypta (zolmitriptan transdermal microneedle system) for the acute treatment of migraine.
- The CRL cited inconsistent zolmitriptan exposure levels observed across clinical pharmacology studies which were previously identified in the FDA’s discipline review letter (DRL) in September.
- The company plans to meet with the agency to discuss how it can address the deficiencies in its application.
- https://seekingalpha.com/news/3624219-fda-rejects-zosano-pharma-application-for-qtrytpa
Wednesday, October 21, 2020
FDA rejects Zosano Pharma application for migraine med
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