Abbreviated New Drug Application (ANDA)
A simplified FDA submission for generic drug approval that relies on the reference drug's safety and efficacy data, requiring only demonstration of bioequivalence. For peptide drugs, ANDAs apply to chemically synthesised peptides; larger biological peptides use the separate biosimilar pathway.
Technical Context
ANDA requirements: demonstrate pharmaceutical equivalence (same active ingredient, strength, dosage form, route) and bioequivalence (rate and extent of absorption within 80-125% of the reference listed drug in crossover PK study). No new clinical trials for safety or efficacy are needed — the ANDA relies entirely on the reference drug's approval. For peptide drugs, ANDAs are applicable to chemically synthesised peptides where the active ingredient can be precisely characterised and shown to be identical. The FDA's Orange Book lists approved drug products with therapeutic equivalence evaluations. Generic peptide drugs approved through ANDAs can be automatically substituted by pharmacists (AB-rated generics). Note: for biological peptides, the separate biosimilar pathway (351(k)) applies, which requires additional analytical and clinical comparability studies.