Tiny pharma hits a new low with FDA refusing to review company's response to its CRL
Just before the long weekend, tiny Zosano Pharma revealed another blow to its application for approval for a migraine patch.
The FDA said the company’s resubmission for the patch didn’t adequately respond to the deficiencies identified in the FDA’s rejection letter, and that the agency will not review this re-submitted application until a new complete response is submitted.
Fremont, CA-based Zosano sent its response to the FDA last month, trying to resurrect the generic triptan zolmitriptan in a new delivery system known as Qtrypta. The agency in October 2020 rejected the patch over inconsistent exposure levels across multiple clinical trials, as well as other issues.
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