FDA CRL - Baxter Healthcare Corporation

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Baxter Healthcare Corporation regarding its New Drug Application (NDA 213645) for DAPZURA RT (daptomycin) for Injection, originally submitted on June 30, 2020, under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act. The primary non-clinical deficiency stems from an inadequate safety qualification of several compounds, known as leachables, detected in the drug product. These compounds may migrate from the packaging or container into the medication, and the agency found insufficient data to conduct an independent safety review. Baxter is required to provide comprehensive safety information, which may include conducting additional repeated-dose toxicology studies for leachables exceeding 5 mcg/day and submitting a draft protocol for FDA review. Further mutagenicity evaluations for new leachables are also recommended. Additionally, the proposed Prescribing Information and the carton/container labeling do not adhere to FDA content and format regulations, including those found in 21 CFR 201.56 and 201.57. Baxter must submit revised drafts of these materials. The company also needs to resubmit the proposed proprietary name, DAPZURA RT, and provide a comprehensive safety update as mandated by 21 CFR 314.50(d)(5)(vi)(b), detailing significant safety profile changes, retabulated adverse events, updated exposure, and worldwide safety experience. Baxter has one year to resubmit the application, fully addressing all identified deficiencies.