For a BMI < 30 kg/m. NDA 204017, held by Agile. Ethinyl Estradiol; Levonorgestrel.
As of Nov 13, 2026, NDA 204017 (Twirla), held by Agile, was first approved by FDA on Feb 14, 2020, with 2 approved supplements and 3 published complete response letters.
TWIRLA is indicated as a method of contraception for use in women of reproductive potential with a BMI < 30 kg/m 2 for whom a combined hormonal contraceptive is appropriate. Limitation of Use Consider TWIRLA’s reduced effectiveness in women with a BMI ≥ 25 to < 30 kg/m 2 before prescribing TWIRLA. TWIRLA is contraindicated in women with a BMI ≥ 30 kg/m 2.
| Date | Submission | Status | Documents |
|---|---|---|---|
| Feb 14, 2020 | Original applicationNew dosage form · Standard review | Approved |
| Dec 21, 2017 | Levonorgestrel/ethinyl estradiolProduct Quality, Clinical, Prea Requirements | Approved |
| Jul 17, 2013 | NDA 204017Clinical, Chemistry, Manufacturing And Controls (Cmc), Path Forward | Approved |
| Feb 13, 2013 | NDA 204017Clinical, Product Quality, Labeling | Approved |
| Product | Active ingredient | Marketing |
|---|---|---|
| Twirla0.01MG/24HR;0.04MG/24HR · system;transdermal | Ethinyl Estradiol; Levonorgestrel | RxReference drug |
| Jun 18, 2026 | Supplement 9Labeling · Standard review | Approved | |
| Apr 29, 2022 | Supplement 4Labeling · Standard review | Approved | |
| Feb 14, 2020 | Original applicationNew dosage form · Standard review | Approved |
Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters
