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The drug or other substance has a potential for abuse less than the drugs or other substances in schedules I and II. The drug or other substance has a currently accepted medical use in treatment in the United States. Abuse of the drug or other substance may lead to moderate or low physical dependence or high psychological dependence.
Description - includes the proprietary name (if any), nonproprietary name, dosage form(s), qualitative and/or quantitative ingredient information, the pharmacologic or therapeutic class of the drug, chemical name and structural formula of the drug, and if appropriate, other important chemical or physical information, such as physical constants ...
Proprietary database identifiers include those assigned by First Databank, Micromedex, MediSpan, Gold Standard Drug Database (published by Elsevier), and Cerner Multum MediSource Lexicon; these are cross-indexed by RxNorm, which also assigns a unique identifier (RxCUI) to every combination of active ingredient and dose level.
The law allows drug companies to find alternative methods of assessing their products, without testing them on animals or human beings. The bill was sponsored by Sens. Rand Paul (R–Ky.) and Cory ...
Risk Evaluation and Mitigation Strategies (REMS) is a program of the US Food and Drug Administration for the monitoring of medications with a high potential for serious adverse effects. REMS applies only to specific prescription drugs, but can apply to brand name or generic drugs. [1] The REMS program was formalized in 2007.
This is a list of abbreviations used in medical prescriptions, including hospital orders (the patient-directed part of which is referred to as sig codes).This list does not include abbreviations for pharmaceuticals or drug name suffixes such as CD, CR, ER, XT (See Time release technology § List of abbreviations for those).
The term specialty drugs was used as early as 1988 in a New York Times article about Eastman Kodak Company's acquisition of the New York-based Sterling Drug Inc., maker of specialty drugs along with many and diverse other products. [2] When Shire Pharmaceuticals acquired BioChem Pharma in 2000 they created a specialty pharmaceuticals company. [32]
Brand name drugs cost more due to time, money, and resources that drug companies invest in them to conduct development, including clinical trials that the FDA requires for the drug to be marketed. [28] Because drug companies have to invest more in research costs to do this, brand name drug prices are much higher when sold to consumers. [28]