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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]
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 ...
In December 2014, the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) approved olaparib as monotherapy. [ 7 ] [ 14 ] [ 13 ] [ 11 ] [ 12 ] The FDA approval is in germline BRCA mutated (gBRCAm) advanced ovarian cancer that has received three or more prior lines of chemotherapy.
Osilodrostat was approved for medical use in the European Union in January 2020, [5] and for medical use in the United States in March 2020. [3] [6] Osilodrostat's safety and effectiveness for treating Cushing's disease among adults was evaluated in a study of 137 adult subjects (about three-quarters women) with a mean age of 41 years. [3]
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]
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This is a complete list of estrogens and formulations that are approved by the FDA Tooltip Food and Drug Administration and available in the United States. Estrogens are used as hormonal contraceptives , in hormone replacement therapy , and in the treatment of gynecological disorders .
As of August 2020, the drug was under Food and Drug Administration (FDA) priority review for small-cell lung cancer with an application decision date of February 15, 2021. [ 26 ] Although CDK4/6 inhibitors have had the most success, CDK inhibitors targeting other CDKs are also undergoing clinical trials.