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- Abbreviated_New_Drug_Application abstract "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 is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which 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. Electronic submissions of ANDAs have grown by 70% since November 2008. The Section IV challenge has been credited with suppressing new drug innovation.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 in vitro) and clinical (human) trial 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. In cases of topically active drugs, the bioequivalence of a drug can be demonstrated by comparing drugs dissolution or transdermal drug absorption is compared with the innovator drug. In cases of systemically active drugs, active drug blood concentration of that drug is compared with 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 trials. 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.".
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- Abbreviated_New_Drug_Application wikiPageWikiLink Approved_Drug_Products_with_Therapeutic_Equivalence_Evaluations.
- Abbreviated_New_Drug_Application wikiPageWikiLink Approved_drug.
- Abbreviated_New_Drug_Application wikiPageWikiLink Bioavailability.
- Abbreviated_New_Drug_Application wikiPageWikiLink Bioequivalence.
- Abbreviated_New_Drug_Application wikiPageWikiLink Bioequivalent.
- Abbreviated_New_Drug_Application wikiPageWikiLink Bloodstream.
- Abbreviated_New_Drug_Application wikiPageWikiLink Brand.
- Abbreviated_New_Drug_Application wikiPageWikiLink Brand-name.
- Abbreviated_New_Drug_Application wikiPageWikiLink Category:Food_and_Drug_Administration.
- Abbreviated_New_Drug_Application wikiPageWikiLink Center_for_Drug_Evaluation_and_Research.
- Abbreviated_New_Drug_Application wikiPageWikiLink Circulatory_system.
- Abbreviated_New_Drug_Application wikiPageWikiLink Clinical_trial.
- Abbreviated_New_Drug_Application wikiPageWikiLink Concise_Encyclopedia_of_Economics.
- Abbreviated_New_Drug_Application wikiPageWikiLink David_R._Henderson.
- Abbreviated_New_Drug_Application wikiPageWikiLink Drug_Price_Competition_and_Patent_Term_Restoration_Act.
- Abbreviated_New_Drug_Application wikiPageWikiLink Food_and_Drug_Administration.
- Abbreviated_New_Drug_Application wikiPageWikiLink Generic_drug.
- Abbreviated_New_Drug_Application wikiPageWikiLink Innovator_drug.
- Abbreviated_New_Drug_Application wikiPageWikiLink Library_of_Economics_and_Liberty.
- Abbreviated_New_Drug_Application wikiPageWikiLink Medication.
- Abbreviated_New_Drug_Application wikiPageWikiLink Pharmaceutical_drug.
- Abbreviated_New_Drug_Application wikiPageWikiLink The_Concise_Encyclopedia_of_Economics.
- Abbreviated_New_Drug_Application wikiPageWikiLinkText "ANDA".
- Abbreviated_New_Drug_Application wikiPageWikiLinkText "Abbreviated New Drug Application".
- Abbreviated_New_Drug_Application hasPhotoCollection Abbreviated_New_Drug_Application.
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- Abbreviated_New_Drug_Application wikiPageUsesTemplate Template:Regulation_of_therapeutic_goods_in_the_United_States.
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- Abbreviated_New_Drug_Application subject Category:Food_and_Drug_Administration.
- Abbreviated_New_Drug_Application hypernym Application.
- Abbreviated_New_Drug_Application type Article.
- Abbreviated_New_Drug_Application type Drug.
- Abbreviated_New_Drug_Application type Software.
- Abbreviated_New_Drug_Application type Work.
- Abbreviated_New_Drug_Application type Agency.
- Abbreviated_New_Drug_Application type Article.
- Abbreviated_New_Drug_Application type Drug.
- Abbreviated_New_Drug_Application type Publication.
- Abbreviated_New_Drug_Application type Source.
- Abbreviated_New_Drug_Application type Work.
- Abbreviated_New_Drug_Application comment "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 is submitted to FDA's Center for Drug Evaluation and Research, Office of Generic Drugs, which 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.".
- Abbreviated_New_Drug_Application label "Abbreviated New Drug Application".
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- Abbreviated_New_Drug_Application sameAs Q4664417.
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