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`Drug Approvals and Databases > Drugs@FDA Glossary of Terms
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`Drugs@FDA Glossary of Terms
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`Abbreviated New Drug Application (ANDA)
`An Abbreviated New Drug Application (ANDA) contains data that, when submitted to FDA's Center for Drug Evaluation and Research, Office of Generic
`Drugs, provides for the review and ultimate approval of a generic drug product. Generic drug applications are called "abbreviated" because they are
`generally not required to include preclinical (animal) and clinical (human) data to establish safety and effectiveness.
`Instead, a generic applicant must
`scientifically demonstrate that its product is bioequivalent (i.e., performs in the same manner as the innovator drug). 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 (ANDA) Number
`This six-digit number is assigned by FDA staff to each application for approval to market a generic drug in the United States.
`
`Active Ingredient
`An active ingredient is any component that provides pharmacological activity or other direct effect in the diagnosis, cure, mitigation, treatment, or
`prevention of disease, or to affect the structure or any function of the body of man or animals.
`
`Approval History
`The approval history is a chronological list of all FDA actions involving one drug product having a particular FDA Application number (NDA). There are ove
`50 kinds of approval actions including changes in the labeling, a new route of administration, and a new patient population for a drug product.
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`Application
`See New Drug Application (NDA), Abbreviated New Drug Application ANDA), or Biologic License Application (BLA)
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`Approval Letter
`An official communication from FDA to a new drug application (NDA) sponsor that allows the commercial marketing of the product.
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`Application Number
`See FDA Application Number
`
`Biologic License Application (BLA)
`Biological products are approved for marketing under the provisions of the Public Health Service (PHS) Act. The Act requires a firm who manufactures a
`biologic for sale in interstate commerce to hold a license for the product. A biologics license application is a submission that contains specific information
`on the manufacturing processes, chemistry, pharmacology, clinical pharmacology and the medical affects of the biologic product. If the information
`provided meets FDA requirements, the application is approved and a license is issued allowing the firm to market the product.
`
`Biological Product
`Biological products include a wide range of products such as vaccines, blood and blood components, allergenics, somatic cells, gene therapy, tissues, and
`recombinant therapeutic proteins. Biologics can be composed of sugars, proteins, or nucleic acids or complex combinations of these substances, or may be
`living entities such as cells and tissues. Biologics are isolated from a variety of natural sources — human, animal, or microorganism — and may be
`produced by biotechnology methods and other cutting-edge technologies. Gene-based and cellular biologics, for example, often are at the forefront of
`biomedical research, and may be used to treat a variety of medical conditions for which no other treatments are available.
`In general, the term "drugs" includes therapeutic biological products.
`Brand Name Drug
`A brand name drug is a drug marketed under a proprietary, trademark-protected name.
`
`Chemical Type
`The Chemical Type represents the newness of a drug formulation or a new indication for an existing drug formulation. For example, Chemical Type 1 is
`assigned to an active ingredient that has never before been marketed in the United States in any form.
`(list of Chemical Types and their meaningsi)
`
`Company
`The company (also called applicant or sponsor) submits an application to FDA for approval to market a drug product in the United States.
`
`Discontinued Drug Product
`Products listed in Drugs@FDA as "discontinued" are approved products that have never been marketed, have been discontinued from marketing, are for
`military use, are for export only, or have had their approvals withdrawn for reasons other than safety or efficacy after being discontinued from marketing.
`
`Dosage Form
`A dosage form is the physical form in which a drug is produced and dispensed, such as a tablet, a capsule, or an injectable.
`
`Drug
`A drug is defined as:
`- A substance recognized by an official pharmacopoeia or formulary.
`- A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
`- A substance (other than food) intended to affect the structure or any function of the body.
`- A substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device.
`- Biological products are included within this definition and are generally covered by the same laws and regulations, but differences exist regarding
`their manufacturing processes (chemical process versus biological process.)
`Drug Product
`The finished dosage form that contains a drug substance, generally, but not necessarily in association with other active or inactive ingredients.
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`FDA Action Date
`The action date tells when an FDA regulatory action, such as an original or supplemental approval, took place.
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`FDA Application Number
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`Drug Approvals and Databases > Drugs@FDA Glossary of Terms
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`This number, also known as the NDA (New Drug Application) number, is assigned by FDA staff to each application for approval to market a new drug in th:
`United States. One drug can have more than one application number if it has different dosage forms or routes of administration
`
`Generic Drug
`A generic drug is the same as a brand name drug in dosage, safety, strength, how it is taken, quality, performance, and intended use. Before approving a
`generic drug product, FDA requires many rigorous tests and procedures to assure that the generic drug can be substituted for the brand name drug. The
`FDA bases evaluations of substitutability, or "therapeutic equivalence," of generic drugs on scientific evaluations. By law, a generic drug product must
`contain the identical amounts of the same active ingredient(s) as the brand name product. Drug products evaluated as "therapeutically equivalent" can be
`expected to have equal effect and no difference when substituted for the brand name product.
`
`Label
`The FDA approved label is the official description of a drug product which includes indication (what the drug is used for); who should take it; adverse
`events (side effects); instructions for uses in pregnancy, children, and other populations; and safety information for the patient. Labels are often found
`inside drug product packaging.
`
`Marketing Status
`Marketing status indicates how a drug product is sold in the United States. Drug products in Drugs@FDA are identified as:
`- Prescription
`- Over-the-counter
`- Discontinued
`
`- None - drug products that have been tentatively approved
`
`Medication Guide
`A medication guide contains information for patients on how to safely use a drug product.
`
`NDA (see New Drug Application)
`
`New Drug Application (NDA)
`When the sponsor of a new drug believes that enough evidence on the drug's safety and effectiveness has been obtained to meet FDA's requirements for
`marketing approval, the sponsor submits to FDA a new drug application (NDA). The application must contain data from specific technical viewpoints for
`review, including chemistry, pharmacology, medical, biopharmaceutics, and statistics. If the NDA is approved, the product may be marketed in the United
`States. For internal tracking purposes, all NDA's are assigned an NDA number.
`
`New Drug Application (NDA) Number
`This six digit number is assigned by FDA staff to each application for approval to market a new drug in the United States. A drug can have more than one
`application number if it has different dosage forms or routes of administration. In Drugs@FDA, you can find the NDA number under the column named
`"FDA Application."
`
`NME (see New Molecular Entity)
`
`New Molecular Entity (NME)
`A New Molecular Entity is an active ingredient that has never before been marketed in the United States in any form.
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`Over-the-Counter Drugs (OTC)
`FDA defines OTC drugs as safe and effective for use by the general public without a doctor's prescription.
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`Patient Package Insert (PPI)
`A patient package insert contains information for patients‘ understanding of how to safely use a drug product.
`
`Pharmaceutical Equivalents
`FDA considers drug products to be pharmaceutical equivalents if they meet these three criteria:
`-
`they contain the same active ingredient(s)
`-
`they are of the same dosage form and route of administration
`-
`they are identical in strength or concentration
`Pharmaceutically equivalent drug products may differ in characteristics such as
`- shape
`-
`release mechanism
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`labeling (to some extent)
`-
`- scoring
`- excipients (including colors, flavors, preservatives)
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`Prescription Drug Product
`A prescription drug product requires a doctor's authorization to purchase.
`
`Product Number
`A product number is assigned to each drug product associated with an NDA (New Drug Application).
`there are multiple product numbers.
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`Reference Listed Drug (see RLD)
`
`If a drug product is available in multiple strengths,
`
`Review
`A review is the basis of FDA's decision to approve an application. It is a comprehensive analysis of clinical trial data and other information prepared by
`FDA drug application reviewers. A review is divided into sections on medical analysis, chemistry, clinical pharmacology, biopharmaceutics, pharmacology,
`statistics, and microbiology.
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`Review Classification
`
`The NDA and BLA classification system provides a way of describing drug applications upon initial receipt and throughout the review process and
`prioritizing their review. (List of Review Classifications and their meaningsz)
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`RLD (Reference Listed Drug)
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`A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug
`company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By
`designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible
`significant variations among generic drugs and their brand name counterpart.
`
`Route
`A route of administration is a way of administering a drug to a site in a patient. A comprehensive list of specific routes of administration appears in the
`CDER Data Standards Manua|3.
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`Strength
`The strength of a drug product tells how much of the active ingredient is present in each dosage.
`
`Supplement
`A supplement is an application to allow a company to make changes in a product that already has an approved new drug application (NDA). CDER must
`approve all important NDA changes (in packaging or ingredients, for instance) to ensure the conditions originally set for the product are still met.
`
`Supplement Number
`A supplement number is associated with an existing FDA New Drug Application (NDA) number. Companies are allowed to make changes to drugs or their
`labels after they have been approved. To change a label, market a new dosage or strength of a drug, or change the way it manufactures a drug, a
`company must submit a supplemental new drug application (sNDA). Each sNDA is assigned a number which is usually, but not always, sequential, starting
`with 001.
`
`Supplement Type
`Companies are allowed to make changes to drugs or their labels after they have been approved. To change a label, market a new dosage or strength of a
`drug, or change the way it manufactures a drug, a company must submit a supplemental new drug application (sNDA). The supplement type refers to the
`kind of change that was approved by FDA. This includes changes in manufacturing, patient population, and formulation.
`
`Tentative Approval
`If a generic drug product is ready for approval before the expiration of any patents or exclusivities accorded to the reference listed drug product, FDA
`issues a tentative approval letter to the applicant. The tentative approval letter details the circumstances associated with the tentative approval. FDA
`delays final approval of the generic drug product until all patent or exclusivity issues have been resolved. A tentative approval does not allow the applicant
`to market the generic drug product.
`
`Therapeutic Biological Product
`A therapeutic biological product is a protein derived from living material (such as cells or tissues) used to treat or cure disease.
`
`Therapeutic Equivalence (TE)
`Drug products classified as therapeutically equivalent can be substituted with the full expectation that the substituted product will produce the same clinica
`effect and safety profile as the prescribed product. Drug products are considered to be therapeutically equivalent only if they meet these criteria:
`-
`they are pharmaceutical equivalents (contain the same active ingredient(s); dosage form and route of administration; and strength.)
`-
`they are assigned by FDA the same therapeutic equivalence codes starting with the letter "A ." To receive a letter "A", FDA
`- designates a brand name drug or a generic drug to be the Reference Listed Drug (RLD).
`- assigns therapeutic equivalence codes based on data that a drug sponsor submits in an ANDA to scientifically demonstrate that its product is
`bioequivalent (i.e., performs in the same manner as the Reference IJsted Drug).
`
`Therapeutic Equivalence (TE) Codes
`The coding system for therapeutic equivalence evaluations allows users to determine whether FDA has evaluated a particular approved product as
`therapeutically equivalent to other pharmaceutically equivalent products (first letter) and to provide additional information on the basis of FDA's
`evaluations (second letter). Sample TE codes: AA, AB, BC (More on TE Codes4)
`
`- FDA assigns therapeutic equivalence codes to pharmaceutically equivalent drug products. A drug product is deemed to be therapeutically equivalen
`("A" rated) only if:
`- a drug company's approved application contains adequate scientific evidence establishing through in viva and/or in vitro studies the bioequivalence
`of the product to a selected reference listed drug.
`those active ingredients or dosage forms for which no in vivo bioequivalence issue is known or suspected.
`
`-
`
`- Some drug products have more than one TE Code.
`- Those products which the FDA does not deem to be therapeutically equivalent are "B" rated.
`Over-the-counter drugs are not assigned TE codes.
`
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`Drug Approvals and Databases > Drugs@FDA Glossary of Terms
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`f U.S. Department of Healih 8: Human Services
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`Links on this page:
`1. ss|_INK/ucm075234.htm#chemtype_reviewc|ass
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`2. ss|_INK/ucm075234.htm#chemtype_reviewc|ass
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`3. /Drugs/Deve|opmentApprova|Process/FormssubmissionRequirements/Electronicsubmissions/DatastandardsManua|monographs/ucm071666.htn'
`4. ssLI N K/ucm079068.htm #TEC
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