Abbreviated New Drug Application (ANDA) Regulatory affairs PDF

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An Abbreviated New Drug Application (ANDA) is a submission to the U.S. Food and Drug Administration (FDA) for the review and potential approval of a generic drug product¹². The ANDA contains data which demonstrates that the generic product performs in the same manner as the innovator drug in terms of bioavailability and bioequivalence¹.

The generic version must deliver the same amount of active ingredients into a patient’s bloodstream in the same amount of time as the innovator drug¹. This demonstration of “bioequivalence” gives the rate of absorption, or bioavailability, of the generic drug, which can then be compared to that of the innovator drug¹.

The ANDA process is based on the Hatch-Waxman Amendments and the Drug Price Competition and Patent Term Restoration Act of 1984¹. These Amendments permit FDA to approve applications to market generic versions of brand-name drugs without repeating costly and duplicative clinical trials to establish safety and efficacy¹.

Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, lower cost alternative to the brand-name drug it references¹². All approved products, both innovator and generic, are listed in FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book)