Abbreviated New Drug Application (ANDA)

An Abbreviated New Drug Application (ANDA) refers to a type of data submitted to the U.S. Food and Drug Administration (FDA) for the purposes of reviewing and approving potential generic drug product. Once the FDA approves the submitted drug, the applicant is allowed to manufacture the generic drug and market it as per the required standards.

A generic drug is similar to an exclusive drug product in terms of pharmacodynamics, pharmacokinetics as well as dosage form only that these drugs provide a cheaper alternative option to the general option. On approval, an ANDA just like any innovator drug is indexed in FDA's Approved Drug Products with Therapeutic Equivalence Evaluations.

The process of submitting an ANDA is quite intensive and demanding. A pharmaceutical company first needs to prove to the FDA that the drug under consideration is bioequivalent to the brand-name drug. These are accomplished via statistical analysis of the two drugs to establish the differences in their functionality.

The analysis is quite extensive an involves clinical trials with the aim of achieving bioequivalence with the non-generic drug. A gold standard of determining bioequivalence is to determine the time taken by the drug to be detected in the bloodstream of healthy individuals in a clinical trial. The time taken for the drug to be detected in the bloodstream is similar to the bioavailability of the generic drug under consideration and can be used for comparison with the original drug.

There are several factors that the FDA must first look at before approving a generic drug. To begin with, information relating to the newly established drug including a unique name, marketing name, chemical composition and name, means and route of administration(s) and the intended use must be accurate and clearly listed. The name of the brand-name that the listed drug relates to is also provided.
Related: FDA Forms Generally Used in Pharmaceutical Inspection

Additionally, vital information indicating whether the drug is contraindicated to certain medical conditions or allergies or if the drug can be sold over-the-counter or prescription only is checked. The applicant is also required to provide supporting data concerning drug manufacturing controls, chemistry as well as other technical information.
Related: Drug Master File and Types of DMF

According to the " Drug Price Competition and Patent Term Restoration Act of 1984", bioequivalence is the primary ground in which a generic drug is approved by the FDA. These provisions commonly referred to as Hatch-Waxman Amendments allows FDA to approve generic drug applications based only on bioequivalence and not efficacy or safety of the drug which require expensive and prolonged clinical trials. This Act also permits brand-name companies to apply for exclusive patent rights to cover their new drugs for up to five years.

Since November 2008, ANDAs have grown by an impressive 70% pointing at substantial growth in generic drug companies. Out of this, 52% of ANDAs are submitted electronically. The main challenge with generic drugs is that they significantly slow down efforts in the innovation of new drugs to combat emerging diseases as well as provide an alternative therapy in the phase of drug resistance. Nevertheless, generic drugs offer a cheaper alternative to brand names which are quite expensive but with similar therapeutic outcomes.