FDA CRL - Baxter Healthcare Corporation

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) on March 29, 2024, to Baxter Healthcare Corporation concerning its New Drug Application (NDA 218224/218524) for an injection product. The agency concluded that the application, in its current form, cannot be approved, citing deficiencies primarily related to product quality, prescribing information, and safety data. Specifically, the proposed Prescribing Information (PI) does not conform to FDA content and format regulations (21 CFR 201.56(a) and (d), 201.57). Baxter must resubmit revised PI that is responsive to prior FDA communications, incorporates corrections based on the SRPI checklist, and is provided in Structured Product Labeling (SPL) format, including both marked-up and clean versions. A comprehensive safety update, as detailed under 21 CFR 314.50(d)(5)(vi)(b), is also required. This update must describe significant changes in the safety profile, integrate and compare new safety data from clinical studies, provide reasons for trial discontinuations, include case report forms and narrative summaries for deaths or serious adverse events, update exposure information, summarize worldwide safety experience, and submit English translations of current foreign labeling. Additionally, the company must provide the chemical name and structural formula for evaluation. Baxter is required to resubmit a complete response, addressing all identified deficiencies, within one year, clearly marking it as "RESUBMISSION." Failure to do so may lead to the application's withdrawal. The company may also request a meeting with the FDA to discuss these requirements.