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In the documentary, filmmaker Liz Canner takes a job editing erotic movies for a drug trial for a pharmaceutical company called Vivus. Her employer is developing what they hope will be the first Viagra drug for women that wins FDA approval to treat a new disease: female sexual dysfunction (FSD). Liz gains permission to film the company's work ...
Pharmaceutical fraud is when pharmaceutical companies engage in illegal, fraudulent activities to the detriment of patients and/or insurers. Examples include counterfeit drugs that do not contain the active ingredient, false claims in packaging and marketing, suppression of negative information regarding the efficacy or safety of the drug, and violating pricing regulations.
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]
Federal regulators are increasingly approving medicines before studies have shown they work, leaving patients at risk of taking prescriptions that could harm but not help them.
The agency also sent a warning letter to Veronvy, which offers unapproved and misbranded oral GLP-1 products, including one that claims to be approved by the FDA. US FDA warns online vendors ...
[9] [10] It was approved for use in the US for HIV in 2015, [11] and for hepatitis B in 2016. [12] Although the US Food and Drug Administration (FDA) has approved tenofovir alafenamide for manufacture as a generic medication , [ 13 ] it is not available.
Flibanserin, sold under the brand name Addyi, is a medication approved for the treatment of pre-menopausal women with hypoactive sexual desire disorder (HSDD). [4] [5] The medication improves sexual desire, increases the number of satisfying sexual events, and decreases the distress associated with low sexual desire. [6]
The FDA also stated that it has not approved any drug containing estriol and that no information had been submitted to the FDA regarding its safety and effectiveness. [11] The FDA's concerns over the marketing and use of bioidentical hormones were supported by the American Association of Clinical Endocrinologists. [ 62 ]