estradiol valerate and estradiol valerate/dienogest

FDA Drug Profile — Estradiol Valerate and Estradiol Valerate/Dienogest, Natazia

Drug Details

Generic Name
estradiol valerate and estradiol valerate/dienogest
Brand Names
Estradiol Valerate and Estradiol Valerate/Dienogest, Natazia
Application Number
NDA022252
Sponsor
Sandoz Inc
NDC Codes
2
Dosage Forms
KIT
Routes
N/A
Active Ingredients
N/A

Indications and Usage

1 INDICATIONS AND USAGE • Natazia is a combination of dienogest , a progestin, and estradiol valerate, an estrogen, indicated for use by females of reproductive potential to prevent pregnancy. ( 1 ) • The efficacy of Natazia in females of reproductive potential with a body mass index (BMI) of >30 kg/m 2 has not been evaluated. ( 1 , 8.8 ) • Treatment of heavy menstrual bleeding in females of reproductive potential without organic pathology who choose to use an oral contraceptive as their method of contraception. ( 1.2 ) 1.1 Oral Contraception Natazia ® is indicated for use by women to prevent pregnancy. The efficacy of Natazia in women with a body mass index (BMI) of > 30 kg/m 2 has not been evaluated. 1.2 Heavy Menstrual Bleeding Natazia is also indicated for the treatment of heavy menstrual bleeding in women without organic pathology who choose to use an oral contraceptive as their method of contraception [see Clinical Studies ( 14.2 )].