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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.
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 ...
The iPLEDGE program is a risk evaluation and mitigation strategy (REMS). The Food and Drug Administration (FDA) may require a REMS to help ensure that a medication’s benefits outweigh its risks ...
These medications were designated as specialty drugs and required specialty pharmacies. When the FDA approves a new drug they may require a REMS program which "may contain any combination of 5 criteria: Medication Guide, Communication Plan, Elements to Assure Safe Use, Implementation System, and Timetable for Submission of Assessments". "In ...
Vigabatrin, sold under the brand names Sabril and Vigpoder, 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, and is a structural analogue of GABA, but does not bind to GABA ...
Sodium oxybate is the sodium salt of γ-hydroxybutyric acid (GHB). Its systematic chemical name is sodium 4-hydroxybutanoate, though synonyms like sodium γ-hydroxybutyrate are commonly used. Its condensed structural formula is HOCH. 2CH.
Each dose of brexucabtagene autoleucel is a customized treatment created using the recipient's own immune system to help fight the lymphoma. [10] The recipient's T cells, a type of white blood cell, are collected and genetically modified to include a new gene that facilitates the targeting and killing of the lymphoma cells. [10]
Tysabri (natalizumab) is a prescription drug used for relapsing-remitting multiple sclerosis (MS), active secondary progressive MS, and clinically isolated syndrome. Tysabri does not come as a ...