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# Complete Response Letter for Zosano’s Qtrypta
- URL: https://www.fdaweb.com/complete-response-letter-for-zosanos-qtrypta/
- Published: 2020-10-21T12:00:00.000Z
- Updated: 2026-09-14T16:33:31.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5147919

FDA has issued a complete response letter in connection with Zosano Pharma’s 505(b)(2) NDA for its Qtrypta (zolmitriptan transdermal microneedle system). The [letter](https://www.google.com/url?sa=t&rct=j&q=&esrc=s&source=newssearch&cd=&cad=rja&uact=8&ved=0ahUKEwiNh5P9jsbsAhUBl3IEHeu1B4gQxfQBCD8wAg&url=https%3A%2F%2Fwww.globenewswire.com%2Fnews-release%2F2020%2F10%2F21%2F2111872%2F0%2Fen%2FZosano-Pharma-Receives-Complete-Response-Letter-from-FDA-for-Qtrypta.html&usg=AOvVaw2qQ%5F%5FvnQ9sF4YB12-5pEQP) reportedly cites inconsistent zolmitriptan exposure levels observed across clinical pharmacology studies.

The company says the agency recommended that Zosano conduct a repeat bioequivalence study between three of the lots used during development.

Company executives say they are seeking a meeting with FDA officials to discuss strategies to address the letter’s comments and resubmit the NDA.