Abbreviated New Drug Application (ANDA)

A federal application to sell or market a generic drug in the US under Section 505(j) of the Food, Drug and Cosmetic Act ( (21 U.S.C.355(j)). The application is "abbreviated" in that it generally does not need to include animal study or clinical trial data, which are generally part of a New Drug Application ( (NDA).

Instead, the ANDA must show that the generic drug is "bioequivalent" to the innovator drug, which means that it delivers the same amount of active ingredient to a patient's bloodstream over the same amount of time as the innovator drug. Specifically, the ANDA must show that the proposed generic drug is the same as the innovator drug in:

  • Dosage form and strength.

  • Route of administration.

  • Quality and performance characteristics.

  • Intended use.

The ANDA must include one or more of four certifications regarding any patent covering the innovator drug. This may include a certification that the patent is invalid or will not be infringed by the ANDA applicant's sale of the proposed generic product (Paragraph IV certification), which may trigger a patent infringement suit.

For more information, see Practice Note, Hatch-Waxman Act: Overview ( .

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