Guidance: ANDA vs 505b(2) Pathway
Determining Whether to Submit an ANDA or a 505(b)(2) Application
Criteria, Considerations and Directions to applicants regarding abbreviated approval pathways, section 505(j) and 505(b)(2)
- 505(b)(2) application: NDA with safety and effectiveness reports, with at least some information from studies not conducted by/for applicant and applicant has not obtained right of reference/use
- 505(j) ANDA application: Duplicate of a previously approved drug product ( reference listed drug-RLD), with no safety and effectiveness reports, have same active ingredient(s), conditions of use, route of administration, dosage form, strength, labeling and bioequivalent to RLD
- Petitioned ANDA: Drug product that differs from RLD in dosage form, route of administration, strength, or active ingredient, with a suitability petition to not provide safety and effectiveness reports
Regulatory Considerations for ANDAs and 505(b)(2) Applications
- Duplicates
- Petitioned ANDAs
- Bundling
Scientific Considerations for ANDAs and 505(b)(2) Applications
- Limited Confirmatory Studies
- Active Ingredient Sameness Evaluation
- Intentional Differences Between the Proposed Drug Product and the RLD