Abbreviated New Drug Application (ANDA)

How It Works

The ANDA pathway was established by the Hatch-Waxman Act of 1984 to make generic drug approval faster and cheaper. Instead of conducting new clinical trials, a generic manufacturer must demonstrate that its product is bioequivalent to the reference drug — meaning it delivers the same amount of active ingredient to the same site in the body at the same rate. This is typically done through pharmacokinetic studies with 24-36 subjects. The ANDA pathway is why generic drugs can cost 80-95% less than brand-name versions — the development cost is a fraction of what the original manufacturer spent.

Related Terms

• FDA Approval — The process by which the U.S. Food and Drug Administration evaluates a drug's safety and efficacy through clinical trial data before allowing it to be marketed.
• Generic Drug — A medication that contains the same active ingredient, dosage, and form as a brand-name drug, approved after the original's patent expires — typically costing 80-95% less.
• Bioequivalence — A regulatory standard proving that a generic drug delivers the same amount of active ingredient to the bloodstream at the same rate as the brand-name drug.