Abbreviated New Drug Application (ANDA)

DEFINITION of 'Abbreviated New Drug Application (ANDA)'

A written request to the U.S. Food and Drug Administration (FDA) to manufacture and market a generic drug in the United States. Abbreviated New Drug Applications are “abbreviated” since they do not require the applicant to conduct clinical trials and require less information than a New Drug Application. If an ANDA is approved, the generic drug will be listed in the Orange Book, which lists all medicines the FDA has found to be safe and effective. An ANDA contains the information the FDA  needs to evaluate how safe and effective a proposed generic drug is compared with its brand-name equivalent. The FDA will not approve the generic unless it is equally safe and effective.

BREAKING DOWN 'Abbreviated New Drug Application (ANDA)'

A company that wants to market a generic drug needs to show the FDA that the drug has been found to be bioequivalent through testing the generic against the brand-name version on a small group of test subjects. Statistical analysis of the test samples must show that there is no significant difference between the two. This process is considerably less rigorous than the clinical trials that new drugs must go through. An exception applies to biosimilars, the generic equivalents of biologic drugs. Biosimilars may require clinical trials because it is harder to achieve bioequivalence with these drugs.

An ANDA lists the new drug’s established name, trade name (if any), chemical name, dosage form(s) and strength(s), route of administration and proposed use. It asks for the name of the listed drug product that the proposed generic is equivalent to. It asks if the drug is for the treatment of a rare disease, and whether the drug will be over-the-counter or prescription-only. The applicant may be required to attach supplemental data about drug chemistry, manufacturing and controls and other technical information.