ZSAN - Zosano Pharma confirms NDA resubmission strategy for Qtrypta

Zosano Pharma ([[ZSAN]] +1.3%) has received the official Type A meeting minutes from the U.S. FDA regarding the requirements for resubmission of its Qtrypta (zolmitriptan transdermal microneedle system) New Drug Application ((NDA)) following the Complete Response Letter it received in October.The FDA recommended a skin assessment on patients in the planned PK study to generate additional safety information.The Type A meeting minutes were generally consistent with the company’s expectations, it said and added that it plans to conduct an additional pharmacokinetic ((PK)) study for inclusion in an NDA resubmission package.

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Zosano Pharma confirms NDA resubmission strategy for Qtrypta