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Numerous governmental and non-governmental organizations have criticized the U. S. Food and Drug Administration for alleged excessive and/or insufficient regulation.The U.S. Food and Drug Administration (FDA) is an agency of the United States Department of Health and Human Services and is responsible for the safety regulation of most types of foods, dietary supplements, drugs, vaccines ...
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 September 2000 Danco Laboratories, a sub-licencee of the Population Council, received approval from the US Food and Drug Administration (FDA) to sell mifepristone under the brand name Mifeprex. In 2019, the first generic form of mifepristone in the United States became available, manufactured by GenBioPro .
About Compounded Tirzepatide. Compounded tirzepatide is a formulation of tirzepatide — a medication for type 2 diabetes and weight loss. Tirzepatide is the active ingredient in the FDA-approved ...
NuvaRing was first approved in The Netherlands in February 2001, then by the European Union in June 2001, and in the United States by the US Food and Drug Administration (FDA) in October 2001. [39] [40] NuvaRing was first marketed in the United States in July 2002, [41] followed by a number European countries since then. [42]
A New Drug Application of bremelanotide for female sexual dysfunction was accepted by the US Food and Drug Administration (FDA) in June 2018, with a Prescription Drug User Fee Act (PDUFA) goal date set for 23 March 2019. [30] It was approved for use in the United States in June 2019. [3] [31] [32]
The United States Food and Drugs Administration is warning pet owners about a common medication given to pets to treat arthritis. The F.D.A. now says that the drug Librela may be associated with ...
A 2020 Cochrane systematic review did not find enough evidence of reduction of all-cause mortality, serious adverse events, cardiovascular mortality, non-fatal myocardial infarction, non-fatal stroke or end-stage renal disease when comparing metformin monotherapy to Thiazolidinedione for treatment of type 2 diabetes.