FDA Clarifies Approval Pathways for ANDA, 505(b)(2) Applications in New Draft Guidance

In new draft guidance, the FDA describes which abbreviated approval pathways are available for ANDAs and 505(b)(2) applications.

The guidance emphasizes regulatory considerations for drugmakers in both cases. For example, the agency generally will refuse to file 505(b)(2) applications for drugs that are duplicates of listed drugs.

Meanwhile, when applicants submit multiple drugs with the same API for approval, there are certain cases where some products would qualify as an ANDA while others would qualify under the 505(b)(2) pathway. In such cases, applicants may submit a single 505(b)(2) application.