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 over 50 kinds of approval actions including changes in the labeling, a new route of administration, and a new patient population for a drug product.

Application

See New Drug Application (NDA), Abbreviated New Drug Application ANDA), or Biologic License Application (BLA)

 

Approval Letter

An official communication from FDA to a new drug application (NDA) sponsor that allows the commercial marketing of the product.

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.

 

Biologic Product

A biologic product is any virus, serum, toxin, antitoxin, vaccine, blood, blood component or derivative, allergenic product, or analogous product applicable to the prevention, treatment, or cure of diseases or injuries.  Biologic products are a subset of "drug products" distinguished by their manufacturing processes (biological process vs. chemical process). In general, the term "drugs" includes biologic products.

 

Brand Name Drug

A brand name drug is a drug marketed under a proprietary, trademark-protected name.

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

A discontinued drug is a drug product that has been removed from the market in the United States for reasons other than safety or effectiveness.

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 of a medicine but not a device or a component, part or accessory of a device.
• Biologic 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 vs. 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.

FDA Action Date

The action date tells when any FDA regulatory action, such as an original or supplemental approval took place.

FDA Application Number

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 the 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 - Drug products that have been removed from the market for reasons   
     other than safety or effectiveness
• None - Drug products that have been tentatively approved

 

Medication Guide

A medication guide contains information for patients' understanding of 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."

Over-the-Counter Drugs (OTC)

FDA defines OTC drugs as safe and effective for use by the general public without a doctor's prescription.

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
• labeling (to some extent)
• scoring
• excipients (including colors, flavors, preservatives)

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).  If a drug product is available in multiple strengths, there are multiple product numbers.

Reference Listed Drug (see RLD)

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.

RLD (Reference Listed Drug) 

A Reference Listed Drug 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 Manual.

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 Equivalence (TE)

Drug products classified as therapeutically equivalent can be substituted with the full expectation that the substituted product will produce the same clinical 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 Listed 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 Codes)

• FDA assigns therapeutic equivalence codes to pharmaceutical equivalent drug products. A drug product is deemed to be therapeutically equivalent ("A" rated) only if 

  • a drug company's approved application contains adequate scientific evidence establishing through in vivo 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 may have more than one TE Code. (More about multiple TE Codes)

• Those products which the FDA does not deem to be therapeutically equivalent are "B" rated.  (More on TE Codes)

Over-the-counter drugs are not assigned TE codes

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