Posted from: Monday, October 31, 2016 - 03:41 PM - Present

First Vagifem Generic Launched

October 17, 2016 - The first generic version of Vagifem®, manufactured by for Novo Nordisk, was released in the U.S. by Amneal Pharmaceuticals and is called Yuvafem® (estradiol vaginal inserts). Each insert of Yuvafem contains a low dose of estradiol intended to treat atrophic vaginitis (dryness, irritation, itching and pain) after menopause. Dosing is one insert per day for the first two weeks, then two inserts per week spaced about three days apart. Yuvafem will be dispensed in packages of eight and 18 inserts in disposable applicators. Its labeling carries boxed warnings common to all estrogens that indicates when used alone it may raise the risk of breast or endometrial cancers, blood clots or strokes. In addition, when used along with a progestin, estrogens may contribute to cardiovascular conditions and possibly to dementia. IMS Health estimates that sales of Vagifem totaled $423 million for the 12-month period ending July 31, 2016.


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Last Updated Friday, September 20, 2019 - 08:56 PM.