View source for Abbreviated New Drug Application

{{Regulation of therapeutic goods in the United States}}
An '''Abbreviated New Drug Application''' (ANDA) is an application for a U.S. [[generic drug]] approval for an existing licensed [[medication]] or [[approved drug]]. 

The ANDA contains data which when submitted to [[Food and Drug Administration|FDA]]'s [[Center for Drug Evaluation and Research]], Office of Generic Drugs, provides for the review and ultimate approval of a generic drug product. Once approved, an applicant may manufacture and market the generic drug product to provide a safe, effective, low cost alternative to the American public. ANDAs have grown by 70% since November 2008.<ref name="The eCTD summit blog">{{cite news|work=The eCTD summit|date=June 30, 2009|author=Kathie Clark |url=http://theectdsummit.com/summit/?p=468|title=DIA Update: News from the FDA}}</ref> The Section IV challenge has been credited with suppressing new drug innovation.<ref>http://www.sciencemag.org/cgi/content/full/326/5951/370</ref>

A generic drug product is one that is comparable to an [[innovator drug]] product in dosage form, strength, route of administration, quality, performance characteristics and intended use.  All approved products, both innovator and generic, are listed in FDA's [[Approved Drug Products with Therapeutic Equivalence Evaluations]] (Orange Book).

Generic drug applications are termed "abbreviated" because they are generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.  Instead, generic applicants must scientifically demonstrate that their product is [[bioequivalent]] (i.e., performs in the same manner as the innovator drug).  One way scientists demonstrate bioequivalence is to measure the time it takes the generic drug to reach the [[bloodstream]] in 24 to 36 healthy volunteers.  This gives them the rate of absorption, or [[bioavailability]], of the generic drug, which they can then compare to that of the innovator drug.  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 drug.  

Using [[bioequivalence]] as the basis for approving generic copies of drug products was established by the [[Drug Price Competition and Patent Term Restoration Act]] of 1984, also known as the Hatch-Waxman Act. This Act expedites the availability of less costly generic drugs by permitting FDA to approve applications to market generic versions of [[brand-name]] drugs without conducting costly and duplicative [[clinical trial]]s.  At the same time, the brand-name companies can apply for up to five additional years longer patent protection for the new medicines they developed to make up for time lost while their products were going through FDA's approval process. Brand-name drugs are subject to the same bioequivalence tests as generics upon reformulation.

==Notes==
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==External links==
{{USDHHS-PD}}
*[http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/AbbreviatedNewDrugApplicationANDAGenerics/default.htm FDA source]

[[Category:Food and Drug Administration|ANDA]]

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