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inducing pioneering research and development of new drugs and; enabling competitors to bring low-cost, generic copies of those drugs to market'". [1] The Orange Book identifies drug products approved on the basis of safety and effectiveness by the Food and Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act.
The therapeutic index (TI; also referred to as therapeutic ratio) is a quantitative measurement of the relative safety of a drug with regard to risk of overdose. It is a comparison of the amount of a therapeutic agent that causes toxicity to the amount that causes the therapeutic effect . [ 1 ]
Prescription drug list prices in the United States continually are among the highest in the world. [1] [2] The high cost of prescription drugs became a major topic of discussion in the 21st century, leading up to the American health care reform debate of 2009, and received renewed attention in 2015.
Before a drug can be prescribed, it must undergo the FDA's approval process. While a drug can feasibly be used off-label (for non-approved indications), it still is required to be approved for a specific disease or medical condition. [2] Drug companies seeking to sell a drug in the United States must first test it.
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 medications). [ 4 ]
When a doctor or another healthcare professional prescribes a drug, the insurer informs the pharmacy of the drug’s tier. The pharmacy then charges the person the appropriate copayment.
Drug Trade name Type Main indications Company Sales (USD millions/year) ∆ vs 2014 1 Adalimumab: Humira Biologic Rheumatoid arthritis: AbbVie Inc. 14,012 1,469 2 Ledipasvir/sofosbuvir: Harvoni Small molecule Hepatitis C: Gilead Sciences: 13,864 11,737 3 Etanercept: Enbrel Biologic Rheumatoid arthritis: Amgen. Pfizer. 8,697 4,009 4 Infliximab ...
Geroscience has a long way to go, but there are four FDA-approved drugs that have shown promise to “target the process of aging,” Barzilai says. While not approved as anti-aging treatments ...