Zosano Pharma Corp

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Zosano Pharma Receives Discipline Review Letter From U.S. FDA

Published: 09/30/2020 22:03 GMT
Zosano Pharma Corp (ZSAN) - Zosano Pharma Corp - on Sept 29, Received Discipline Review Letter From U.S. FDA in Connection With Qtrypta New Drug Application.
Zosano Pharma Corp - Drl Described Two Concerns With Respect to Clinical Pharmacology Section of NDA.
Zosano Pharma Corp - FDA Raised Questions Regarding Unexpected High Plasma Concentrations of Zolmitriptan Observed in 5 Study Subjects.
Zosano Pharma - FDA Raised Questions Regarding Differences in Zolmitriptan Exposures Observed Between Subjects Receiving Different Lots of Qtrypta.
Zosano Pharma Corp - Approval of Qtrypta by Prescription Drug User Fee Act Goal Date of October 20, 2020 is Not Expected.