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Glossary of Drugs Terms
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.
-
- 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:
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:
- 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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