FDA CRL - Accord Healthcare, Inc.

The U.S. Food and Drug Administration (FDA) issued a Complete Response Letter (CRL) to Accord Healthcare, Inc. on April 30, 2021, regarding its New Drug Application (NDA 215000) for Carmustine for injection, originally submitted on June 30, 2020. This action, under section 505(b)(2) of the Federal Food, Drug, and Cosmetic Act, indicates that the application cannot be approved in its current form due to several deficiencies.

Key issues identified relate to Product Quality, requiring Accord Healthcare to conduct a leachable study under worst-case conditions and justify the proposed Acceptable Exposure Threshold (AET) and Permitted Daily Exposure (PDE). Regarding Prescribing Information, detailed comments are reserved until other deficiencies are addressed, with emphasis on adhering to labeling regulations and submitting updated content in Structured Product Labeling (SPL) format.

Furthermore, a comprehensive Safety Update is mandated for resubmission. This includes detailing significant changes in the safety profile, incorporating new clinical and nonclinical safety data, providing comparative tables of adverse event frequencies, retabulating trial discontinuations, submitting case report forms and narrative summaries for deaths and serious adverse events, providing updated exposure information, summarizing worldwide safety experience, and supplying English translations of current approved foreign labeling.

Accord Healthcare, Inc. must fully address all identified deficiencies and resubmit the application within one year, clearly marking it as a "RESUBMISSION." The company also has the option to request a meeting with the FDA to discuss the necessary steps for approval.