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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:
In the US, where a system of quasi-private healthcare is in place, a formulary is a list of prescription drugs available to enrollees, and a tiered formulary provides financial incentives for patients to select lower-cost drugs. For example, under a 3-tier formulary, the first tier typically includes generic drugs with the lowest cost sharing ...
Ciclosporin is indicated to treat and prevent graft-versus-host disease in bone marrow transplantation and to prevent rejection of kidney, heart, and liver transplants. [8] [7] It is also approved in the US for treating of rheumatoid arthritis and psoriasis, persistent nummular keratitis following adenoviral keratoconjunctivitis, [25] [7] and as eye drops for treating dry eyes caused by ...
Drugs subject to USP standards include both human drugs (prescription, over-the-counter, or otherwise) and animal drugs. USP-NF standards also have a role in US federal law ; a drug or drug ingredient with a name recognized in USP-NF is considered adulterated if it does not satisfy compendial standards for strength, quality, or purity.
Many brand name drugs have cheaper generic drug substitutes that are therapeutically and biochemically equivalent. Prescriptions will also contain instructions on whether the prescriber will allow the pharmacist to substitute a generic version of the drug. This instruction is communicated in a number of ways.
Drug nomenclature is the systematic naming of drugs, especially pharmaceutical drugs.In the majority of circumstances, drugs have 3 types of names: chemical names, the most important of which is the IUPAC name; generic or nonproprietary names, the most important of which are international nonproprietary names (INNs); and trade names, which are brand names. [1]
The 340B Drug Pricing Program is a US federal government program created in 1992 that requires drug manufacturers to provide outpatient drugs to eligible health care organizations and covered entities at significantly reduced prices. The intent of the program is to allow covered entities to "stretch scarce federal resources as far as possible ...
The drug or other substance has a high potential for abuse. The drug or other substance has a currently accepted medical use in treatment in the United States or a currently accepted medical use with severe restrictions. Abuse of the drug or other substances may lead to severe psychological or physical dependence.