FDA CRL - Teva Pharmaceuticals USA, Inc.

Teva Pharmaceuticals USA, Inc. submitted an Abbreviated New Drug Application (ANDA 090589) for Epinephrine Injection USP, 0.15 mg/0.3 mL and 0.3 mg/0.3 mL (Auto-Injectors) under section 505(j) of the Federal Food, Drug, and Cosmetic Act. The FDA reviewed the application and amendments submitted between 2009 and 2015 but determined it could not approve the ANDA in its current form due to several deficiencies.

Key issues identified include incomplete release specifications for the epinephrine auto-injectors and trainer devices, lacking essential performance requirements such as needle dimensions and injection depth. There is also an absence of a comprehensive comparison of design and performance specifications for the two product presentations (0.3 mg and 0.15 mg). Additionally, the application does not provide a design control document ensuring the design and performance of the device components are verified and validated.

The labeling suggests injections can occur through clothing, but there are no design requirements or performance data to support this claim. Furthermore, the application lacks a device hazards analysis to confirm that potential delivery errors have been identified and mitigated.

The FDA requires Teva to address these deficiencies by revising release specifications, providing a complete comparison of product presentations, submitting a design control document, validating injection through clothing, and conducting a device hazards analysis. These actions are necessary to ensure the safety and efficacy of the epinephrine auto-injector products.