Antares Pharma, Inc – FDA CRL

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Antares Pharma, Inc. (c/o Halozyme Therapeutics, Inc.) regarding its New Drug Application (NDA 218026) for hydrocortisone sodium phosphate injection. The FDA could not approve the application in its current form due to several outstanding issues. A key concern involves unresolved observations at the drug product manufacturing site, which require satisfactory resolution prior to any potential approval. The FDA also noted deficiencies in the proposed Prescribing Information (PI), requiring submission of revised labeling that conforms to regulatory content and format requirements (e.g., 21 CFR 201.56 and 201.57) and is provided in structured product labeling (SPL) format. While the proposed proprietary name was conditionally acceptable, it must be resubmitted once all other deficiencies are addressed. Additionally, Antares Pharma is required to submit a comprehensive safety update, in accordance with 21 CFR 314.50(d)(5)(vi)(b), including new clinical and nonclinical data, combined safety tabulations, and worldwide experience. The company has one year to resubmit the application, fully addressing all identified deficiencies, or the application may be considered withdrawn under 21 CFR 314.65. The product cannot be legally marketed until written approval is received.