ANDA

Also known as: Abbreviated New Drug Application

The FDA pathway for approving a generic copy of a previously-approved small-molecule drug.

Definition

An Abbreviated New Drug Application is the FDA submission for a generic small-molecule drug. The applicant must demonstrate bioequivalence to the brand reference product but does not need to repeat clinical safety/efficacy trials. Reviewed by the FDA Office of Generic Drugs (OGD).

See also

• Generic drug — A bioequivalent copy of a small-molecule drug after its patent and exclusivity expire.
• Hatch-Waxman — The 1984 US law that created the modern generic-drug approval pathway and 30-month patent stay.

Other regulatory terms

• NDA
• BLA
• PDUFA date
• Priority review
• Breakthrough Therapy
• Accelerated approval