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.

  • 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 ( www.practicallaw.com/9-523-2397) .

{ "siteName" : "PLC", "objType" : "PLC_Doc_C", "objID" : "1247890034391", "objName" : "Abbreviated New Drug Application (ANDA)", "userID" : "2", "objUrl" : "http://us.practicallaw.com/cs/Satellite/us/resource/2-543-2465?null", "pageType" : "Resource", "academicUserID" : "", "contentAccessed" : "true", "analyticsPermCookie" : "2-40e00097:15b19122c8f:-698e", "analyticsSessionCookie" : "2-40e00097:15b19122c8f:-698d", "statisticSensorPath" : "http://analytics.practicallaw.com/sensor/statistic" }