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Phentermine is an norepinephrine and dopamine releasing agent (NDRA) and produces stimulant, rewarding, and appetite suppressant effects. [8] [9] [10] Chemically, it is a substituted amphetamine. [11] Phentermine was approved for medical use in the United States in 1959. [3] It is available as a generic medication. [3]
The Prescribing Information follows one of two formats: "physician labeling rule" format or "old" (non-PLR) format. For "old" format labeling a "product title" may be listed first and may include the proprietary name (if any), the nonproprietary name, dosage form(s), and other information about the product.
The Compendium of Pharmaceuticals and Specialties: The Canadian Drug Reference for Health Professionals, more commonly known by its abbreviation CPS, [1] is a reference book that contains drug monographs and numerous features which help healthcare professionals prescribe and use drugs safely and appropriately.
In 1984, researchers at the University of Rochester Medical Center reported that they had performed a double-blind, controlled clinical trial comparing phentermine alone, fenfluramine alone, a combination of phentermine and fenfluramine, and placebo, for weight loss in humans. Weight loss in those receiving the fen-phen combination was ...
This is the list of Schedule IV controlled substances in the United States as defined by the Controlled Substances Act. [1] The following findings are required for substances to be placed in this schedule: [2]
Phentermine and topiramate was developed by Vivus, a California pharmaceutical company. In December 2009, Vivus, Inc. submitted a new drug application (NDA) to the FDA and on 1 March 2010, Vivus, Inc. announced that the FDA accepted the NDA for review.
Common disk-shaped tablets. A tablet (also known as a pill) is a pharmaceutical oral dosage form (oral solid dosage, or OSD) or solid unit dosage form.Tablets may be defined as the solid unit dosage form of medication with suitable excipients.
In the United States, DMFs are submitted to the Food and Drug Administration (FDA). The Main Objective of the DMF is to support regulatory requirements and to prove the quality, safety and efficacy of the medicinal product for obtaining an Investigational New Drug Application (IND), a New Drug Application (NDA),As an Abbreviated New Drug Application (ANDA), another DMF, or an Export Application.