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# FDA Stalls Xspray Pharma’s Dasynoc
- URL: https://www.fdaweb.com/fda-stalls-xspray-pharmas-dasynoc/
- Published: 2023-07-11T12:00:00.000Z
- Updated: 2026-09-14T18:43:13.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154854

FDA has issued a complete response letter to Sweden’s Xspray Pharma for its NDA for Dasynoc (dasatinib amorphous) to treat chronic myeloid leukemia, its first product to be reviewed by the agency. The company [says](https://xspraypharma.com/modular%5Ffinance%5Fpressmeddelande/xspray-pharma-receives-request-for-additional-information-concerning-dasynoc-from-fda/?ref=fdaweb.com) FDA requested additional information regarding additional information to doctors and users related to the drug’s dosing and regarding a third-party manufacturing facility. FDA also accepted the proposed name and did not identify any deficiencies with the stability or clinical data submitted to it to date, Xspray says.