segesterone acetate and ethinyl estradiol
Drug Details
- Generic Name
- segesterone acetate and ethinyl estradiol
- Brand Names
- Annovera
- Application Number
- NDA209627
- Sponsor
- Mayne Pharma
- NDC Codes
- 1
- Dosage Forms
- RING
- Routes
- VAGINAL
- Active Ingredients
- ETHINYL ESTRADIOL, SEGESTERONE ACETATE
Indications and Usage
1 INDICATIONS AND USAGE ANNOVERA is indicated for use by females of reproductive potential to prevent pregnancy. ANNOVERA is a progestin/estrogen CHC indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) Limitations of Usage Not adequately evaluated in females with a body mass index of >29 kg/m 2 . ( 1 ) Limitations of Use ANNOVERA has not been adequately studied in females with a BMI >29 kg/m 2 .