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Flurpiridaz F-18 is a fluorine 18-labeled agent developed by Lantheus Medical Imaging for the diagnosis of coronary artery disease. [6]The efficacy and safety of flurpiridaz (18 F) were evaluated in two prospective, multicenter, open-label clinical studies in adults with either suspected CAD (Study 1: NCT03354273) or known or suspected CAD (Study 2: NCT01347710). [3]
The following are settlements reached with US authorities against pharmaceutical companies to resolve allegations of "off-label" promotion of drugs. Under the Federal Food, Drug, and Cosmetic Act, it is illegal for pharmaceutical companies to promote their products for uses not approved by the Food and Drug Administration (FDA), and corporations that market drugs for off-label indications may ...
In the United States, the FDA approves drugs.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]
The U.S. Food and Drug Administration (FDA) has cleared the first continuous glucose monitors (CGMs) for over-the-counter sale—a major win for health freedom and common sense. "Giving more ...
The FDA’s full approval of SYMVESS is a transformational event for the Company and our bioengineering technology platform. Even more importantly, we believe SYMVESS provides a new means of treating patients with devastating arterial injuries, which is a population that has not benefited from substantial innovation in decades.
Despite these challenges, Fluosol-DA was approved by the FDA and was marketed as a blood substitute in the United States from 1989 through 1994 when it was withdrawn from the market due to poor sales. [16] Perftoran was approved in the Soviet Union in 1994 and remained in limited use in Russia at least as late as 2019. [17]
The Food and Drug Administration (FDA) announced in a statement Tuesday that it has sent warning letters to companies selling unapproved weight loss drugs. The letter went to Xcel Peptides ...
While red No. 3 has been banned from cosmetics in the U.S. since 1990, the dye – one of nine synthetic dyes approved for use in the U.S. – remains in food products.. However, the FDA has two ...