Zealand Pharma US, Inc. – FDA CRL

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Zealand Pharma US, Inc. regarding its New Drug Application (NDA 217724) for dasiglucagon injection, indicating that the application cannot be approved in its present form. The FDA identified several key deficiencies that require resolution. A significant issue stems from current good manufacturing practice (CGMP) inspection deficiencies at a manufacturing facility listed in the application. Satisfactory responses to these deficiencies, potentially requiring re-inspection and successful outcomes from Pre-Approval Inspections (PAI) and CGMP surveillance, are necessary. Additionally, the submitted prescribing information was found non-responsive to prior communications and contained formatting errors. Zealand Pharma must revise the labeling to conform to regulatory standards (e.g., 21 CFR 201.56(a) and (d)) and submit it in Structured Product Labeling (SPL) format. The proposed proprietary name review was terminated and requires resubmission after other deficiencies are addressed. Furthermore, the FDA mandates a comprehensive safety update, as per 21 CFR 314.50(d)(5)(vi)(b), including new clinical and nonclinical data, detailed analyses, and global safety experience. The company must also clarify and propose labeling language concerning dasiglucagon dosing based on age and body weight, specifically for infants under 4.1 kg, for whom clinical data is lacking. Addressing these issues is crucial for potential approval.