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Abbreviated New Drug Application (ANDA)
What is an Abbreviated New Drug Application (ANDA)? An Abbreviated New Drug Application is used to seek approval from the FDA for manufacturing and marketing a generic drug product. The purpose is to produce an alternative to the brand-name drug that is equally effective for the given indication but is lower in cost.
What is required by the ANDA?
Unlike a new drug application (NDA) used to gain approval for novel drugs, the ANDA does not usually require all the components needed for the NDA, including data from pre-clinical and clinical studies previously used to establish drug safety and efficacy.
ANDA instead requires that the manufacturer can show bioequivalence to the brand drug, with similarity demonstrated in:
- Drug ingredients, including quality and purity
- Intended use
- Route of administration
- Dosage forms and strength