Approved Drug Products with Therapeutic Equivalence Evaluations
Encyclopedia
Drug, Price and Competition Act
(1984)- FDA
required to publish Approved Drug Products with Therapeutic Equivalence and Evaluations. Doesn’t include drugs before 1938. Orange Book. Supposed to use in pharmacy
all the time.
The publication, Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug
products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act
(the Act). Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation
[DESI] review [e.g., Donnatal
Tablets and Librax
Capsules] or pre-1938 drugs [e.g., Phenobarbital
Tablets]) are not included in this publication. The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy
reasons. Inclusion of products on the List is independent of any current regulatory action through administrative or judicial means against a drug product. In addition, the List contains therapeutic equivalence evaluations for approved multisource prescription drug
products. These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education
in the area of drug product selection and to foster containment of health care
costs. Therapeutic equivalence evaluations in this publication are not official FDA actions affecting the legal status of products under the Act.
Drug Price Competition and Patent Term Restoration Act
-Overview:The Drug Price Competition and Patent Term Restoration Act, informally known as the "Hatch-Waxman Act" [Public Law 98-417], is a 1984 United States federal law which established the modern system of generic drugs...
(1984)- FDA
Food and Drug Administration
The Food and Drug Administration is an agency of the United States Department of Health and Human Services, one of the United States federal executive departments...
required to publish Approved Drug Products with Therapeutic Equivalence and Evaluations. Doesn’t include drugs before 1938. Orange Book. Supposed to use in pharmacy
Pharmacy
Pharmacy is the health profession that links the health sciences with the chemical sciences and it is charged with ensuring the safe and effective use of pharmaceutical drugs...
all the time.
The publication, Approved Drug Products with Therapeutic Equivalence Evaluations (the List, commonly known as the Orange Book), identifies drug
Drug
A drug, broadly speaking, is any substance that, when absorbed into the body of a living organism, alters normal bodily function. There is no single, precise definition, as there are different meanings in drug control law, government regulations, medicine, and colloquial usage.In pharmacology, a...
products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act
Federal Food, Drug, and Cosmetic Act
The United States Federal Food, Drug, and Cosmetic Act , is a set of laws passed by Congress in 1938 giving authority to the U.S. Food and Drug Administration to oversee the safety of food, drugs, and cosmetics. A principal author of this law was Royal S. Copeland, a three-term U.S. Senator from...
(the Act). Drugs on the market approved only on the basis of safety (covered by the ongoing Drug Efficacy Study Implementation
Drug Efficacy Study Implementation
Drug Efficacy Study Implementation was a program begun by the Food and Drug Administration in the 1960s after the requirement that all drugs be efficacious as well as safe. The DESI program was intended to classify all pre-1962 drugs that were already on the market as either effective,...
[DESI] review [e.g., Donnatal
Donnatal
Donnatal is a proprietary combination medication for the treatment of intestinal cramping due to various causes, often administered as part of a GI Cocktail. It is classed as an anticholinergic antispasmodic drug. Donnatal is marketed by PBM Pharmaceuticals. It is available as tablets, capsules,...
Tablets and Librax
Librax
Librax is a drug consisting of chlordiazepoxide and clidinium bromide and used to treat peptic ulcers, irritable bowel syndrome , and gastritis. It helps relieve stomach spasms, abdominal cramps, and anxiety related to gastric disorders...
Capsules] or pre-1938 drugs [e.g., Phenobarbital
Phenobarbital
Phenobarbital or phenobarbitone is a barbiturate, first marketed as Luminal by Friedr. Bayer et comp. It is the most widely used anticonvulsant worldwide, and the oldest still commonly used. It also has sedative and hypnotic properties but, as with other barbiturates, has been superseded by the...
Tablets]) are not included in this publication. The main criterion for the inclusion of any product is that the product is the subject of an application with an effective approval that has not been withdrawn for safety or efficacy
Efficacy
Efficacy is the capacity to produce an effect. It has different specific meanings in different fields. In medicine, it is the ability of an intervention or drug to reproduce a desired effect in expert hands and under ideal circumstances.- Healthcare :...
reasons. Inclusion of products on the List is independent of any current regulatory action through administrative or judicial means against a drug product. In addition, the List contains therapeutic equivalence evaluations for approved multisource prescription drug
Prescription drug
A prescription medication is a licensed medicine that is regulated by legislation to require a medical prescription before it can be obtained. The term is used to distinguish it from over-the-counter drugs which can be obtained without a prescription...
products. These evaluations have been prepared to serve as public information and advice to state health agencies, prescribers, and pharmacists to promote public education
Public education
State schools, also known in the United States and Canada as public schools,In much of the Commonwealth, including Australia, New Zealand, South Africa, and the United Kingdom, the terms 'public education', 'public school' and 'independent school' are used for private schools, that is, schools...
in the area of drug product selection and to foster containment of health care
Health care
Health care is the diagnosis, treatment, and prevention of disease, illness, injury, and other physical and mental impairments in humans. Health care is delivered by practitioners in medicine, chiropractic, dentistry, nursing, pharmacy, allied health, and other care providers...
costs. Therapeutic equivalence evaluations in this publication are not official FDA actions affecting the legal status of products under the Act.
External links
- http://www.accessdata.fda.gov/scripts/cder/ob/default.cfm