FDA Approved Options for Uterine Fibroids

by | Dec 16, 2020 | FDA, Pharma, Pharmaceuticals, Quality

Uterine fibroids are a diagnosis that many women receive every day, however, it is a diagnosis that women often never hear of until they receive it. Uterine fibroids are defined as noncancerous growths of the uterus that occur during reproductive years. They cause symptoms in 25% of women of reproductive age, they are responsible for one in five visits to a gynecologist, and they account for over 1/3 of all hysterectomies performed in the United States.1 This is a big issue, especially when one considers that the common symptoms of uterine fibroids include: heavy menstrual bleeding with long and painful periods, pelvic pressure with frequent urination, lower back pain, and complications during pregnancy and labor (women with uterine fibroids are six times more likely to need a cesarean section than women without fibroids). 1

While there are treatment options for women suffering from uterine fibroids, the options tend to be inconvenient, and women typically need to use a few treatment options simultaneously. Medical options often offered to women with uterine fibroids include NSAIDS (to relieve pain), hormonal contraceptives (to regulate the menstrual cycle), and different types of acetate injections (to shrink fibroids and control bleeding).

Ideally, there would be one drug that could help with all these symptoms simultaneously. Additionally, getting acetate injections to control menstrual bleeding is not super convenient, and many women choose to not use hormonal birth control, meaning that treatment options can be limited for some women. Luckily, the FDA has recently approved a new oral medication, Oriahnn, which is intended to control menstrual bleeding in women with uterine fibroids.2 It is a combination product, consisting of estrogen, progestin, as well as estradiol, and norethindrone acetate. This combination of hormones with acetates means that this oral medication can help regulate menstrual periods, reduce the amount of blood flow during a period, and possibly help shrink fibroids.

Innovative products like Oriahnn are huge in improving the lives of people who suffer from chronic illnesses. These products would not be able to come to market without following the correct FDA regulatory pathways and ensuring that they comply with the regulatory requirements. If your company is working on any new and innovative drugs, our regulatory experts at EMMA International can help! Contact us at 248-987-4497 or email info@emmainternational.com to get connected with our team of experts today.


1Laughlin-Tommaso, S. (July 2014) Uterine Fibroids: An introduction retrieved on 12/14/2020, from https://www.fda.gov/media/89172/download

2FDA (May 2020) FDA Approves New Option to Treat Heavy Menstrual Bleeding Associated with Fibroids in Women retrieved on 12/14/2020 from https://www.fda.gov/news-events/press-announcements/fda-approves-new-option-treat-heavy-menstrual-bleeding-associated-fibroids-women

Catherine Milford

Catherine Milford

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