FDA approvals for Annovera and Natural Cycles app

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On August 10, 2018, the U.S. Food and Drug Administration made two major announcements related to contraception. First, it permitted marketing of Natural Cycles, a direct-to-consumer app for contraceptive use. Then it approved AnnoveraTM, a combined hormonal contraceptive ring.

Natural Cycles uses an algorithm to calculate the days of the month a woman is likely to be fertile based on daily basal body temperature readings and menstrual cycle information. This fertility-awareness based method is designed for use on mobile devices, among pre-menopausal women aged 18 and older.

Annovera is the first vaginal ring that provides pregnancy protection for a year. It is used for three weeks and then removed for one week, allowing for a withdrawal bleeding period. Annovera, which includes segesterone acetate and ethinyl estradiol, was developed by the Population Council and will be marketed by TherapeuticsMD in the United States.

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