FDA CRL - Teva Pharmaceuticals USA Inc

The FDA issued a Complete Response Letter (CRL) to Teva Pharmaceuticals USA regarding their New Drug Application (NDA 208574) for Romidepsin Injection, 10 mg/2 mL, submitted under section 505(b)(2). The application was not approved due to several outstanding issues.

Primary concerns include product quality deficiencies, specifically an inadequate rationale for potential extractables and leachables from the drug's container system under proposed manufacturing conditions. Teva is required to provide comprehensive data and study results to address this. Significant revisions are also mandated for the proposed prescribing information, which contains error-prone symbols and requires phrasing corrections to align with FDA labeling regulations. Carton and container labeling also needs updates, including the addition of quantitative ingredient and sterility information, and clearer presentation of critical dilution instructions.

Additionally, a recent inspection of Teva Pharmaceutical Works Private Limited Company's manufacturing facility in Gödöllő, Hungary, revealed deficiencies that must be satisfactorily resolved. Teva must also submit a comprehensive safety update, incorporating all new clinical and nonclinical data, detailed safety profile changes, updated exposure information, and worldwide safety experience. Teva is required to fully address all deficiencies within one year for the application to be reconsidered for approval.