Elagolix and Estradiol and Norethisterone
Elagolix and Estradiol and Norethisterone is listed in the FDA National Drug Code directory with 1 NDC code, marketed under brand name including Oriahnn. Available dosage form: kit.
Drug Details
- Generic Name
- Elagolix and Estradiol and Norethisterone
- Brand Names
- Oriahnn
- Application Number
- NDA213388
- Sponsor
- AbbVie Inc.
- NDC Codes
- 1
- Dosage Forms
- KIT
- Routes
- N/A
- Active Ingredients
- N/A
Indications and Usage
1 INDICATIONS AND USAGE ORIAHNN is indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. Limitation of Use: Use of ORIAHNN should be limited to 24 months due to the risk of continued bone loss, which may not be reversible [see Dosage and Administration ( 2.1 ) and Warnings and Precautions ( 5.2 ) ] . ORIAHNN is a combination of elagolix, a gonadotropin-releasing hormone (GnRH) receptor antagonist, estradiol, an estrogen, and norethindrone acetate, a progestin, indicated for the management of heavy menstrual bleeding associated with uterine leiomyomas (fibroids) in premenopausal women. ( 1 ) Limitation of Use: Use of ORIAHNN should be limited to 24 months due to the risk of continued bone loss, which may not be reversible. ( 1 )