Search results
Results from the WOW.Com Content Network
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.
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]
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.
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]
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 .
Get AOL Mail for FREE! Manage your email like never before with travel, photo & document views. Personalize your inbox with themes & tabs. You've Got Mail!
The U.S. Food and Drug Administration (FDA) approved the drug for use in the United States on 13 August 2010, [39] following the FDA advisory committee's recommendation. [ 40 ] [ 41 ] Watson Pharmaceuticals announced the availability of ulipristal acetate in the United States on 1 December 2010, in retail pharmacies, clinics, and one on-line ...