1st generic rival for EpiPen, a birth control app & more: 5 latest FDA approvals

Here are the five latest drugs or medical devices approved by the FDA since Aug. 10:

1. Teva Pharmaceuticals' generic version of EpiPen and EpiPen Jr. are auto-injectors for the emergency treatment of allergic reactions, including those that are life-threatening. The approval brings the first generic competitor to Mylan's EpiPen.

2. Natural Cycles is a direct-to-consumer birth control app. The FDA refers to the app as a "medical app," and it works by calculating the days of the month a woman is most likely ovulating, based on daily basal body temperature readings and menstrual cycle information. The app will display the phrase "use protection" on days the user is most likely to be fertile.

3. Onpattro is a first-of-its-kind RNA-based therapy for the treatment of peripheral nerve disease caused by a rare genetic disease characterized by the buildup of abnormal protein in peripheral nerves. It is intended for use in adults.

4. Annovera, the first combined hormonal vaginal ring contraceptive that can be used for one year, is used to prevent pregnancy in women of reproductive age.

5. Galafold was approved for the treatment of Fabry disease, a rare genetic disease that results from buildup of fat in blood vessels, nerves, the kidneys, the heart and other organs.

Copyright © 2024 Becker's Healthcare. All Rights Reserved. Privacy Policy. Cookie Policy. Linking and Reprinting Policy.

 

Featured Whitepapers

Featured Webinars