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Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book, is a publication produced by the United States Food and Drug Administration (FDA), as required by the Drug Price and Competition Act (Hatch-Waxman Act). The Hatch-Waxman Act was created to '"strike a balance between two competing policy interests ...
e. The Drug Price Competition and Patent Term Restoration Act (Public Law 98-417), informally known as the Hatch-Waxman Act, is a 1984 United States federal law that established the modern system of generic drug regulation in the United States. The Act's two main goals are to facilitate entry of generic drugs into the market and to compensate ...
Orange Book may refer to: Trusted Computer System Evaluation Criteria, a computer security standard. We Can Conquer Unemployment, 1929 manifesto by David Lloyd George and the Liberal Party. The Orange Book: Reclaiming Liberalism, by members of the British Liberal Democrat party. Approved Drug Products with Therapeutic Equivalence Evaluations ...
Ciprofloxacin is a broad-spectrum antibiotic of the fluoroquinolone class. It is active against some Gram-positive and many Gram-negative bacteria. [79] It functions by inhibiting a type II topoisomerase (DNA gyrase) and topoisomerase IV, [80][81] necessary to separate bacterial DNA, thereby inhibiting cell division.
Ethchlorvynol is a member of the class of sedative-hypnotic carbinols, which includes methylparafynol and tert -amyl alcohol. It is not a benzodiazepine, carbamate, or barbituric acid derivative, and its molecular structure is considerably simpler. The systematic name of ethchlorvynol is usually given as ethyl 2-chlorovinyl ethynyl carbinol or ...
In 1962, the Kefauver-Harris Amendment to the FD&C Act gave the FDA the authority to also require efficacy as a condition for drug approval. Drugs approved after June 24, 1938, but before 1962 had a limited time to be reviewed for efficacy in order to remain on the market. This was known as the Drug Efficacy Study Implementation (DESI).
Isosorbide dinitrate. Isosorbide dinitrate is a medication used for heart failure, esophageal spasms, and to treat and prevent chest pain from not enough blood flow to the heart. [1] It has been found to be particularly useful in heart failure due to systolic dysfunction together with hydralazine. [2][1] It is taken by mouth or under the tongue.
The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services.The FDA is responsible for protecting and promoting public health through the control and supervision of food safety, tobacco products, caffeine products, dietary supplements, prescription and over-the-counter pharmaceutical drugs (medications), vaccines ...