Xspray Pharma AB – FDA CRL

Xspray Pharma AB has received a Complete Response Letter from the FDA regarding its New Drug Application (NDA 216195) for dasatinib tablets, indicating the application cannot be approved in its current form. The primary regulatory concerns center on the high risk of medication errors. The FDA determined that Xspray’s proposed tablet strengths and naming conventions are too similar to existing products, which could lead to dangerous dosing mistakes. Furthermore, previous label comprehension studies failed to demonstrate that users could safely distinguish the product. Beyond clinical concerns, the FDA identified manufacturing deficiencies during recent Current Good Manufacturing Practice (CGMP) and pre-approval inspections at a contract facility. These facility issues must be resolved, potentially requiring re-inspection, before approval can be granted. To address these deficiencies under the 21 CFR 314.110 framework, Xspray must choose one of two paths: conduct new labeling comprehension studies with modified safety warnings or reformulate the drug to either match the reference product’s strengths exactly or create distinct, non-overlapping strengths. The company is also required to submit a comprehensive safety update and ensure the manufacturing facility reaches compliance. Xspray has one year to resubmit the amended application or request an extension.