FDA CRL - Accord Healthcare Inc.

Accord Healthcare Inc. received a Complete Response Letter from the FDA dated November 6, 2025, regarding its New Drug Application (NDA 216987) for bendamustine hydrochloride injection. The FDA determined the application cannot be approved in its current form due to significant manufacturing concerns. The primary issues stem from deficiencies identified during facility inspections regarding Current Good Manufacturing Practices. Several facilities associated with the application were issued deficiency reports (FDA Form 483) that remain unresolved at the time of the letter. The FDA emphasized that satisfactory resolution of these manufacturing violations, potentially involving follow-up inspections, is a prerequisite for approval. Furthermore, the agency has deferred its review of the product’s labeling and prescribing information until the manufacturing issues are addressed. To move forward under the 21 CFR 314.110 regulatory framework, Accord Healthcare must submit a comprehensive response within one year. This resubmission must include proof that all facility deficiencies have been corrected and must provide an updated safety report. This safety update must consolidate worldwide clinical data, any new adverse event findings, and patient exposure information. The company is advised that a partial response will not be accepted, and the product remains unapproved for marketing until these requirements are fully met.