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 ( www.practicallaw.com/7-503-3134) (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 ( www.practicallaw.com/4-543-2445) (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.
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 ( www.practicallaw.com/9-523-2397) .