A B C D E F G H I J K L M N O P Q R S T U V W X Y Z
- 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.
- 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 meanings)
- 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 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.
- FDA Action Date
- The action date tells when an
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:
- 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.
- 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:
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.
- 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 meanings)
- RLD (Reference Listed Drug)
- 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 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 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
clinical effect and safety profile as the prescribed product. Drug products are considered to
be therapeutically equivalent only if they meet these
criteria:
- 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 pharmaceutically 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 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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