Elagolix
Drug Details
- Generic Name
- Elagolix
- Brand Names
- Orilissa
- Application Number
- NDA210450
- Sponsor
- AbbVie Inc.
- NDC Codes
- 4
- Dosage Forms
- TABLET, FILM COATED
- Routes
- ORAL
- Active Ingredients
- ELAGOLIX SODIUM, ELAGOLIX
Indications and Usage
1 INDICATIONS AND USAGE ORILISSA is indicated for the management of moderate to severe pain associated with endometriosis. Limitation s of Use: Limit the duration of use based on the dose and coexisting condition (see Table 1 ) [see D osage and Administration ( 2.1 ) and Warnings and Precautions ( 5.1 ) ] . ORILISSA is a gonadotropin-releasing hormone (GnRH) receptor antagonist indicated for the management of moderate to severe pain associated with endometriosis. ( 1 ) Limitation s of Use: Limit the duration of use based on the dose and coexisting condition (see Table 1 ). ( 1 )