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
  • Pharmacokinetics
  • Pharmacodynamics
  • Route of administration
  • Dosage forms and strength

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