USA – When to Submit an ANDA vs. a 505(b)(2)? FDA Explains

The US Food and Drug Administration (FDA) on Thursday finalized guidance to help drug sponsors determine when they should submit an abbreviated new drug application (ANDA) for a generic or a 505(b)(2) application for a drug that partly relies on certain data from an already-approved drug.

Generics approved via ANDAs are common, with hundreds of approvals coming each year, whereas examples of drugs approved under the 505(b)(2) pathway may be less well known but include approvals such as Adapt Pharma’s Narcan nasal spray or follow-on insulin products like Eli Lilly’s Basaglar and Sanofi’s Admelog.

The guidance finalizes a draft from October 2017 and includes minor revisions, including a reworking of a section on scientific considerations for ANDAs and 505(b)(2) applications.

“We note that we received comments requesting clarification on the process for obtaining therapeutic equivalence evaluations. We will address therapeutic equivalence in a forthcoming guidance document,” FDA said in Thursday’s Federal Register.

Differences Between ANDAs and 505(b)(2)

Both ANDA and 505(b)(2) applicants have significant flexibility in the types of studies, data and information they may submit, the guidance says, although ANDA applicants should not submit clinical investigations to establish safety and effectiveness.