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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 result is that apixaban generics will most likely not be available in the United States until at least 2026, but possibly 2031. [18] In July 2022, the Canadian generic drug company, Apotex Inc., obtained approval for marketing of apixaban. [39] [40] Pfizer reported revenue of US$6.747 billion for Eliquis in 2023. [41]
A generic drug is a chemically equivalent, cheaper version of a brand-name drug. A generic drug form is required to have the same dose, strength and active ingredient(s) as the brand name drug; thus, they carry the same risks and benefits. To ensure compliance, the FDA Generic Drugs Program conducts stringent reviews (3,500 inspections of ...
The U.S. government on Tuesday released a list of 10 prescription medicines that will be subject to the first-ever price negotiations by the Medicare health program that covers Americans aged 65 ...
The new drug price negotiations aim "to basically make drugs more affordable while also still allowing for profits to be made,” said Gretchen Jacobson, who researches Medicare issues at ...
Drug companies have argued that Medicare’s price negotiations could chill their research and development, leading to fewer new medications coming to market. This story has been updated with ...