Teva Pharmaceuticals USA Inc – FDA CRL

Teva Pharmaceuticals, Inc. received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) for its Biologics License Application (BLA 761385) for TVB-009, indicating the application cannot be approved in its present form. Key issues identified include deficiencies from a Remote Regulatory Assessment of a manufacturing facility, requiring a satisfactory response and potentially an onsite pre-license inspection. There are also significant concerns regarding product labeling; Teva must submit revised draft prescribing information, carton, and container labeling that adheres to FDA communications, incorporates reference product updates, and meets regulatory content and format requirements, including a specific Medication Guide statement. The FDA acknowledged Teva’s proposed Risk Evaluation and Mitigation Strategy (REMS) for TVB-009, which is deemed necessary to address the risk of severe hypocalcemia, with further discussion to follow a complete response. The conditionally acceptable proprietary name also requires resubmission after all deficiencies are resolved. Furthermore, a comprehensive safety update is mandated, detailing changes in the safety profile, presenting new clinical data, updated adverse event tabulations, case report forms for serious events, worldwide safety experience, and English translations of foreign labeling. Teva is required to resubmit the application or take other actions within one year.