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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

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