While it is important to understand how to navigate the complex generic drug approval pathway, it is first necessary to determine whether your drug product should be submitted as an abbreviated new drug application (ANDA) for approval as a generic or if it requires submission of a 505(b)(2) new drug application. This particular issue is addressed in a draft guidance “Determining Whether to Submit an ANDA or a 505(b)(2) Application.” This article will:
- Provide an overview of the FDA guidance
- Help you understand when a 505(b)(2) application is appropriate and when an ANDA is appropriate
- Reference other guidance documents relevant to the topic