Differences between New drug application (NDA) and Abbreviated New Drug Application (ANDA) are listed below. Drug listed in NDA is a branded drug while in ANDA is a generic drug (a bioequivalent of an branded drug). ADNA can be applied only after the expriy of patent period of the drug.
| NDA | ANDA |
|---|---|
| NDA stands for New Drug Application | ANDA stands for Abbreviated New Drug Application |
| Applicable for new drug (first ever discovered) | It is for generic drug (drug already in market under brand name) |
| Take long time (12-15 years) | 1 - 2 years is enough |
| More expenditure of money | Comparatively less |
| Cost of final new drug is high | Cost of generic drug is low |
| Non-clinical studies and Clinical investigations are essential | Non-clinical studies and Clinical investigations are non essential except bioavailability and bioequivalence |
| NDA Requirements | ANDA Requirements |
|---|---|
| Labelling | Labelling |
| Pharmacology or Toxicology Reports | Pharmacology or Toxicology Reports |
| Chemistry | Chemistry |
| Manufacturing | Manufacturing |
| Controls | Controls |
| Inspection | Inspection |
| Microbiological Test | Microbiological Test |
| Testing | Testing |
|
Animal Studies
Clinical Studies Bioavailabilty |
Bioequivalence (because all other parameters are already studied on brand drug) |
