Abbreviated New Drug Application: This six-digit number is assigned by Food and Drug Administration (FDA) staff to each application for approval to market a generic drug in the United States.

Active Ingredient: Any component that provides pharmacological activity or direct effect in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect any function of the body.

Addiction: A chronic, relapsing disease characterized by compulsive drug-seeking and abuse and by long-lasting chemical changes in the brain.

Adrenal Glands: Glands located above each kidney that secrete hormones, for example, adrenaline.

Amphetamine: Stimulant drugs whose effects are very similar to cocaine.

Amyl Nitrite: A yellowish oily volatile liquid used in certain diagnostic procedures and prescribed to some patients for heart pain. Illegally diverted ampules of amyl nitrite are called “poppers” or “snappers” on the street.

Anabolic Effects: Drug-induced growth or thickening of the body's nonreproductive tract tissues—including skeletal muscle, bones, the larynx, and vocal cords—and decrease in body fat.

Analogue (Designer Drug) Act: An act prohibiting the sale, distribution, or possession of so-called designer drugs, which are mind-altering substances that are chemically altered for the purpose of circumventing existing drug laws, thereby making them legal.

Androgenic Effects: A drug's effects upon the growth of the male reproductive tract and the development of male secondary sexual characteristics.

Anesthetic: An agent that causes insensitivity to pain and is used for surgeries and other medical procedures.

Anti-Drug Abuse Amendment Act: Signed in late 1988 by President Ronald Reagan, the act revised the Anti-Drug Abuse Act of 1986 by closing real or perceived loopholes of that law. Major provisions included the creation of a new executive-level [Page 874]agency, the Office of National Drug Control Policy, whose director, appointed by the president, would lead a uniform national strategy to reduce drug use and availability, and would have unprecedented budgetary certification authority over other department and agency heads.

Aplastic Anemia: A disorder that occurs when the bone marrow produces too few of all three types of blood cells: red blood cells, white blood cells, and platelets.

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

Axon: The fiber-like extension of a neuron by which the cell carries information to target cells.

Axon terminal: The structure at the end of an axon that produces and releases chemicals (neurotransmitters) to transmit the neuron's message across the synapse.

Benzene: A volatile liquid solvent found in gasoline.

Bind: The attaching of a neurotransmitter or other chemical to a receptor. The neurotransmitter is said to “bind” to the receptor.

Boggs Act: Passed in 1951, the act strengthened the enforcement of the Marijuana Tax Act and the Narcotics Drug Import and Export Act by enforcing harsh penalties on individuals convicted of drug law violations.

Brainstem: The major route by which the forebrain sends information to, and receives information from, the spinal cord and peripheral nerves.

Brand Name Drug: A drug marketed under a proprietary, trademark-protected name.

Butane: A substance found in lighter fluid.

Butyl Nitrite: An illegal substance that is often packaged and sold in small bottles; also referred to as “poppers.”

Cannabinoid Receptor: The receptor in the brain that recognizes anandamide and THC, the active ingredient in marijuana.

Cannabinoids: Chemicals that help control mental and physical processes when produced naturally by the body and that produce intoxication and other effects when absorbed from marijuana.

Cannabis: The botanical name for marijuana.

Carcinogen: Any substance that causes cancer.

Cardiovascular System: The heart and blood vessels.

Cell Body (or Soma): The central structure of a neuron, which contains the cell nucleus. The cell body contains the molecular machinery that regulates the activity of the neuron.

Central Nervous System: The brain and spinal cord.

Cerebellum: A portion of the brain that helps regulate posture, balance, and coordination.

Cerebral Cortex: Region of the brain responsible for cognitive functions including reasoning, mood, and perception of stimuli.

Cerebral Hemispheres: The two specialized halves of the brain. The left hemisphere is specialized for speech, writing, language, and calculation; the right hemisphere is specialized for spatial abilities, face recognition in vision, and some aspects of music perception and production.

Cerebrum: The upper part of the brain consisting of the left and right hemispheres.

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 been before marketed in the United States.

Chloroform: A colorless volatile liquid used as a medical anesthetic gas.

[Page 875]Chronic: Refers to a disease or condition that persists over a long period of time.

Coca: The plant, Erythroxylon, from which cocaine is derived. Also refers to the leaves of this plant.

Cocaethylene: A substance created in the body when cocaine and alcohol are used together; chemically similar to cocaine.

Cocaine: A highly addictive stimulant drug derived from the coca plant that produces profound feelings of pleasure.

Comprehensive Drug Abuse Prevention and Control Act of 1970: An act that mandated pharmaceutical companies to maintain strict security measures over certain types of drugs and also to make sure that these drugs are kept secure from potential theft by drug abusers and addicts.

Controlled Substance Registrant Protection Act:

Developed in 1984, the act attempted to nationally standardize and increase penalties for the robbery or theft of controlled substances from registrants, particularly pharmacists. Prior to its passage, the theft of controlled substances from pharmacists or hospitals was not considered to be a federal crime in the United States.

Controlled Substances Penalties Amendments Act of 1984: An act passed under President Ronald Reagan that, among other provisions, doubled penalties for distributing drugs within 1,000 feet of a school.

Crack: Slang term for a smokeable form of cocaine.

Cyclohexyl Nitrite: A chemical found in substances marketed as room deodorizers.

Dendrite: The specialized branches that extend from a neuron's cell body and function to receive messages from other neurons.

Depressants: Drugs that relieve anxiety and produce sleep. Depressants include barbiturates, benzodiazepines, and alcohol.

Dopamine: A brain chemical, classified as a neurotransmitter, found in regions of the brain that regulate movement, emotion, and pleasure.

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 chemical compound or substance that can alter the structure and function of the body. Psychoactive drugs affect the function of the brain, and some of these may be illegal to use and possess.

Drug Abuse: The use of illegal drugs or the inappropriate use of legal drugs. The repeated use of drugs to produce pleasure, to alleviate stress, or to alter or avoid reality (or all three).

Drug Product: The finished dosage form that contains a drug substance, generally, but not necessarily in association with other active or inactive ingredients.

Durham-Humphrey Act: Passed in 1951, the act attempted to define medications as either being prescription drugs or over over-the-counter drugs.

Ecstasy (MDMA): A chemically modified amphetamine that has hallucinogenic as well as stimulant properties.

Eighteenth Amendment to the U.S. Constitution: Taking effect in early 1920, the act prohibited the manufacture, sale, or transportation of intoxicating liquors.

Emphysema: A lung disease in which tissue deterioration results in increased air retention and reduced exchange of gases. The result is difficult breathing and shortness of breath. It is often caused by smoking.

Endogenous: Produced by the brain or body.

Ether: A volatile liquid with a characteristic odor. Used as a medical anesthetic gas.

Euphoria: A physical and/or psychological sense of well-being or elation.

[Page 876]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.

Fluorinated Hydrocarbons: Gases or liquids commonly found in refrigerants, fire extinguishers, solvents, and anesthetics. Freon is one class of fluorinated hydrocarbons.

Forebrain: The largest division of the brain, which includes the cerebral cortex and basal ganglia. It is credited with the highest intellectual functions.

Frontal Lobe: One of the four divisions of each cerebral hemisphere. The frontal lobe is important for controlling movement and associating the functions of other cortical areas.

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” are expected to have equal effect when substituted for the brand name.

Hallucinations: Perceptions of something (such as a visual image or a sound) that does not really exist. Hallucinations arise from a disorder of the nervous system or in response to drugs (such as LSD).

Hallucinogens: A diverse group of drugs that alter perceptions, thoughts, and feelings. Hallucinogenic drugs include LSD, mescaline, MDMA (ecstasy), PCP, and psilocybin (magic mushrooms).

Halothane: Medical anesthetic gas.

Harrison Narcotics Tax Act: An act proposed by Congressional Representative Francis Burton Harrison to “provide for the registration of, with collectors of internal revenue, and to impose a special tax on all persons who produce, import, manufacture, compound, deal in, dispense, sell, distribute, or give away opium or coca leaves, their salts, derivatives, or preparations, and for other purposes.”

Hepatitis: Inflammation of the liver.

Heroin: The potent, widely abused opiate that produces addiction. It consists of two morphine molecules linked together chemically.

Hexane: A hydrocarbon volatile liquid found in glue or gasoline.

Hippocampus: An area of the brain crucial for learning and memory.

Hormone: A chemical substance formed in glands in the body and carried in the blood to organs and tissues, where it influences function and behavior.

Human Immunodeficiency Virus (HIV): The virus that causes acquired immunodeficiency syndrome (AIDS).

Hypothalamus: The part of the brain that controls many bodily functions, including feeding, drinking, and the release of many hormones.

Ingestion: The act of taking in food or other material into the body through the mouth.

Inhalant: Any drug administered by breathing in its vapors. Inhalants commonly are organic solvents, such as glue and paint thinner, or anesthetic gases, such as ether and nitrous oxide.

Inhalation: The act of administering a drug or combination of drugs by nasal or oral respiration. Also, [Page 877]the act of drawing air or other substances into the lungs. Nicotine in tobacco smoke enters the body by inhalation.

Injection: A method of administering a substance such as a drug into the skin, subcutaneous tissue, muscle, blood vessels, or body cavities, usually by means of a needle.

Label: The FDA-approved label is the official description of a drug product that 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.

Limbic system: A set of brain structures that generates our feelings, emotions, and motivations. It is also important in learning and memory.

LSD (lysergic acid diethylamide): An hallucinogenic drug that acts on the serotonin receptor.

Marihuana Tax Act of 1937: The first national marijuana prohibition law, the Act was engineered by Federal Bureau of Narcotics Director Harry Anslinger, who suggested an imposition of a prohibitory tax rather than an outright ban.

Marijuana: A drug, usually smoked but can be eaten, that is made from the leaves of the cannabis plant. The main psychoactive ingredient is THC.

Medication: A drug that is used to treat an illness or disease according to established medical guidelines.

Medication Guide: A medication guide contains information for patients on how to safely use a drug.

Metabolism: The processes by which the body breaks things down so they can be eliminated.

Methamphetamine: A commonly abused stimulant drug from the larger family of amphetamines.

Methylphenidate (Ritalin): Methylphenidate is a central nervous system stimulant. It has effects similar to, but more potent than, caffeine and less potent than amphetamines. It has a “focusing” effect on those with ADHD, particularly children.

Myelin: Fatty material that surrounds and insulates axons of most neurons.

Neuron (Nerve Cell): A unique type of cell found in the brain and body that is specialized to process and transmit information.

Neurotransmission: The process that occurs when a neuron releases neurotransmitters to communicate with another neuron across the synapse.

Neurotransmitter: A chemical produced by neurons to carry messages to other neurons.

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.

Nicotine: The addictive drug in tobacco. Nicotine activates a specific type of acetylcholine receptor.

Nitrites: A special class of inhalants that act primarily to dilate blood vessels and relax the muscles. Whereas other inhalants are used to alter mood, nitrites are used primarily as sexual enhancers. (See also amyl nitrite and butyl nitrite).

Nitrous Oxide: Medical anesthetic gas, especially used in dentistry. Also called “laughing gas.” Found in whipped cream dispensers and gas cylinders.

Noradrenaline: A chemical neurotransmitter that is made in the brain and can affect the heart.

Nucleus: A cluster or group of nerve cells that is dedicated to performing its own special function(s). Nuclei are found in all parts of the brain but are called cortical fields in the cerebral cortex.

Nucleus Accumbens: A part of the brain reward system, located in the limbic system, that processes information related to motivation and reward. Virtually all drugs of abuse act on the nucleus accumbens to reinforce drug taking.

[Page 878]Occipital Lobe: The lobe of the cerebral cortex at the back of the head that includes the visual cortex.

Office of National Drug Control Policy Reauthorization Act of 1998: An act that ensured that “no Federal funds appropriated to the Office of National Drug Control Policy shall be expended for any study or contract relating to the legalization (for a medical use or any other use) of a substance listed in schedule I of section 202 of the Controlled Substances Act.”

Opium Poppy Control Act: Signed into law on December 11, 1942, the purpose of the act was to “discharge more effectively the obligations of the United States under certain treaties relating to the manufacture and distribution of narcotic drugs, by providing for domestic control of the production and distribution of the opium poppy and its products, and for other purposes.”

Over-the-Counter Drugs (OTC): The FDA defines OTC drugs as drugs that are safe and effective for use by the general public without a doctor's prescription.

Parietal Lobe: One of the four subdivisions of the cerebral cortex; it is involved in sensory processes, attention, and language.

Patient Package Insert (PPI): A patient package insert contains information for patients' understanding of how to safely use a drug product.

Physical Dependence: An adaptive physiological state that occurs with regular drug use and results in a withdrawal syndrome when drug use is stopped.

Polyneuropathy: Permanent change or malfunction of nerves.

Prescription Drug: A prescription drug product requires a doctor's authorization to purchase.

Psychoactive Drug: A drug that changes the way the brain works.

Pure Food and Drug Act of 1906: The first national law addressing drugs in U.S. history. The law did not prohibit any drug but rather was aimed at protecting consumers from potentially dangerous products that were being widely sold yet not regulated for safety.

Receptor: A large molecule that recognizes specific chemicals (normally neurotransmitters, hormones, and similar endogenous substances) and transmits the message carried by the chemical into the cell on which the receptor resides.

Reducing Americans' Vulnerability to Ecstasy Act (RAVE Act): An act passed in 2002 to enact tougher sanctions surrounding the use of club drugs, primarily MDMA or ecstasy, during all night dance parties or raves.

Relapse: In drug abuse, relapse is the resumption of drug use after trying to stop taking drugs. Relapse is a common occurrence in many chronic disorders, including addiction, that require behavioral adjustments to treat effectively.

Reuptake: The process by which neurotransmitters are removed from the synapse by being “pumped” through transporters back into the axon terminals that first released them.

Reuptake Pump (Transporter): The large molecule that actually transports neurotransmitter molecules back into the axon terminals that released them.

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

Reward: The process that reinforces behavior. It is mediated at least in part by the release of dopamine [Page 879]into the nucleus accumbens. Human subjects report that reward is associated with feelings of pleasure.

Reward System (or Brain Reward System): A brain circuit that, when activated, reinforces behaviors. The circuit includes the dopamine-containing neurons of the ventral tegmental area, the nucleus accumbens, and part of the prefrontal cortex. The activation of this circuit causes feelings of pleasure.

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 of Administration: The way a drug is put into the body. Drugs can enter the body by eating, drinking, inhaling, injecting, snorting, smoking, or absorbing a drug through mucous membranes.

Rush: A surge of pleasure that rapidly follows administration of some drugs.

Serotonin: A neurotransmitter that regulates many functions, including mood, appetite, and sensory perception.

Sex Hormones: Hormones that are found in higher quantities in one sex than in the other. Male sex hormones are the androgens, which include testosterone; and the female sex hormones are the estrogens and progesterone.

Stimulants: A class of drugs that elevates mood, increases feelings of well-being, and increases energy and alertness. These drugs produce euphoria and are powerfully rewarding. Stimulants include cocaine, methamphetamine, and methylphenidate (Ritalin).

Strength: The strength of a drug product tells how much of the active ingredient is present per 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 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.

Synapse: The site where presynaptic and postsynaptic neurons communicate with each other.

Synaptic Space (or Synaptic Cleft): The intercellular space between the presynaptic and postsynaptic neurons.

Temporal Lobe: The lobe of the cerebral cortex at the side of the head that hears and interprets music and language.

Tentative Approval: If a generic drug product is ready for approval before the expiration of patents or exclusivities accorded to the reference listed drug product, the 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.

Tetrahydrocannabinol: See THC.

Thalamus: Located deep within the brain, the thalamus is the key relay station for sensory information flowing into the brain, filtering important messages from the mass of signals entering the brain.

[Page 880]THC: Delta-9-tetrahydrocannabinol; the main active ingredient in marijuana, which acts on the brain to produce its effects.

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.

Tobacco: A plant widely cultivated for its leaves, which are used primarily for smoking; the tabacum species is the major source of tobacco products.

Tolerance: A condition in which higher doses of a drug are required to produce the same effect as during initial use; often leads to physical dependence.

Toluene: A light colorless liquid solvent found in many commonly abused inhalants, including airplane glue, paint sprays, and paint and nail polish removers.

Transporter: A light colorless liquid solvent found in many commonly abused inhalants, including airplane glue, paint sprays, and paint and nail polish removers.

Trichloroethylene: A liquid used as a solvent and in medicine as an anesthetic and analgesic. Found in cleaning fluid and correction fluid.

Twenty-First Amendment to the U.S. Constitution: Passed by Congress on February 20, 1933, the Twenty-First Amendment officially repealed the Eighteenth Amendment, which was passed to prohibit the manufacture, distribution, and transportation of alcohol within the United States.

Uniform State Narcotic Act: An act that argued that all states should have the same safeguards and regulations when it comes trafficking in narcotics.

Ventral Tegmental Area (VTA): The group of dopamine-containing neurons that make up a key part of the brain reward system. These neurons extend axons to the nucleus accumbens and the prefrontal cortex.

Vesicle: A membranous sac within an axon terminal that stores and releases neurotransmitter.

Volstead Act: The federal law that implemented the Eighteenth Amendment, creating the structure for the enforcement laid out in that amendment.

Webb-Kenyon Act: An act passed in 1913 whose purpose was to allow the federal government to assist, or at least not interfere, with the operation of state laws that prohibited the manufacture, transportation, and sale of alcoholic beverages.

Withdrawal: Symptoms that occur after chronic use of a drug is reduced or stopped.

Sources: U.S. Food and Drug Administration and National Institute on Drug Abuse.