XSpray Pharma receives FDA complete response letter for Dasynoc over GMP issues at contract manufacturer

Reuters2026/08/19 01:22

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XSpray Pharma received an FDA Complete Response Letter for Dasynoc, delaying approval and requiring an NDA resubmission in 2026.
Regulatory issues center on unresolved GMP observations at third-party manufacturer NerPharMa, not Dasynoc clinical data, bioequivalence, or stability.
FDA also requested additional commercial-scale consecutive batch data following corrective actions, adding manufacturing and timing risk to the US launch.
NerPharMa reported remediation completed; FDA has not decided whether a reinspection is needed to close out the facility assessment.
Prior FDA concerns on medication-error risk cited in earlier CRLs have been resolved.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. XSpray Pharma AB (publ) published the original content used to generate this news brief on August 19, 2026, and is solely responsible for the information contained therein.

Disclaimer: The content of this article solely reflects the author's opinion and does not represent the platform in any capacity. This article is not intended to serve as a reference for making investment decisions.

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XSpray Pharma receives FDA complete response letter for Dasynoc over GMP issues at contract manufacturer

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