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Risk Evaluation and Mitigation Strategies. 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 iPLEDGE program is a program by the U.S. Food and Drug Administration (FDA) intended to manage the risk of birth defects caused by isotretinoin (also known as Accutane), [1] a prescription medication used for the treatment of acne. [2][3] Patients, their doctors and their pharmacists are required by the FDA to register and use the iPLEDGE ...
Specialty drugs in the United States. Specialty drugs or specialty pharmaceuticals are a recent designation of pharmaceuticals [1][2] classified as high-cost, [3][4][5] high complexity and/or high touch. [4] Specialty drugs are often biologics [3][6] —"drugs derived from living cells" [7] that are injectable or infused (although some are oral ...
Sodium oxybate, sold under the brand name Xyrem among others, is a medication used to treat symptoms of narcolepsy: sudden muscle weakness and excessive daytime sleepiness. [3] [7] [8] It is used sometimes in France and Italy as an anesthetic given intravenously; [9]: 15, 27–28 it is also approved and used in Italy and in Austria to treat alcohol dependence and alcohol withdrawal syndrome.
Vigabatrin. 5–8 hours in young adults, 12–13 hours in the elderly. Vigabatrin, sold under the brand name Sabril among others, is a medication used in the management and treatment of infantile spasms and refractory complex partial seizures. It works by inhibiting the breakdown of γ-aminobutyric acid (GABA). It is also known as γ-vinyl-GABA ...
Phentermine and topiramate was approved with a risk evaluation and mitigation strategy (REMS) program to ensure that benefits of treatment outweigh the risks. [6]
Brexucabtagene autoleucel is a chimeric antigen receptor T cell therapy and is the first cell-based gene therapy approved by the U.S. Food and Drug Administration (FDA) for the treatment of mantle cell lymphoma. [10] Brexucabtagene autoleucel was approved for medical use in the United States in July 2020, [10][7][13] and in the European Union ...
Celgene. Celgene Corporation is a pharmaceutical company that makes cancer and immunology drugs. Its major product is Revlimid (lenalidomide), which is used in the treatment of multiple myeloma, and also in certain anemias. The company is incorporated in Delaware, headquartered in Summit, New Jersey, and a subsidiary of Bristol Myers Squibb (BMS).