On June 19, 2026, Exeltis USA announced that the FDA has approved an update to the labeled strength of levonorgestrel and ethinyl estradiol (TWIRLA; Exeltis USA) transdermal system. The new labeled strength is expected to begin appearing on the market in September or October of 2026, according to an announcement from Exeltis USA.¹

The revision, said the company, is intended to provide a more accurate representation of the amount of levonorgestrel and ethinyl estradiol delivered, or transferred, to the user from the patch, and is based on residual drug results from Study ATI-CL28.

The change applies to the labeled strength only. There is no change to the formulation, composition, or manufacturing process of the product as a result of this update.

“Until the supply of 120 mcg/30 mcg per day is depleted, patients may receive TWIRLA labeled with either strength, but the dose (1 transdermal system) and its effects are unchanged,” stated Exeltis.

When was levonorgestrel and ethinyl estradiol first approved?

Levonorgestrel and ethinyl estradiol was originally approved by the FDA on February 14, 2020, when it was announced by Agile Therapeutics, Inc.² The product is a birth control patch indicated for women with a body mass index (BMI) of less than 30 kg/m² who can become pregnant, and it contains 2 female hormones: levonorgestrel, a progestin, and ethinyl estradiol, an estrogen. Birth control methods containing both an estrogen and a progestin are classified as combination hormonal contraceptives (CHCs).¹

At the time of original approval, the product was indicated as a method of contraception for women of reproductive potential with a BMI of less than 30 kg/m² for whom a combined hormonal contraceptive is appropriate.² The product was designed for weekly application, delivering a 30 mcg daily dose of ethinyl estradiol and a 120 mcg daily dose of levonorgestrel, and the patch can be worn on the abdomen, buttock, or upper torso, excluding the breasts.²

RELATED: Combined hormonal contraceptives merit risk assessment in patients with obesity

Levonorgestrel/ethinyl estradiol birth control patch is not recommended if:

• Patients smoke cigarettes and are over 35 years old. Smoking increases your risk of serious cardiovascular side effects from combination hormonal contraceptives (CHCs), including death from heart attack, blood clots or stroke. This risk increases with age and the number of cigarettes you smoke.
• Patient’s BMI is 30 kg/m² or more. If you do not know what your BMI is, please talk to your healthcare provider. Women with a BMI of 30 kg/m2 or more who use CHCs may have a higher risk for developing side effects like blood clots compared to women with a BMI lower than 30 kg/m².

References:

1. FDA approves labeled strength update of TWIRLA ((levonorgestrel/ethinyl estradiol) birth control patch. News release. June 19, 2026. Accessed June 19, 2026. https://sg.finance.yahoo.com/news/fda-approves-labeled-strength-twirla
2. FDA approves Agile Therapeutics, Inc’s Twirla (levonorgestrel and ethinyl estradiol) transdermal system - A new weekly contraceptive patch delivering a 30 mcg daily dose of estrogen and 120 mcg daily dose of progestin. News release. Agile. Published February 14, 2020. Accessed June 19, 2026. https://www.biospace.com/fda-approves-agile-therapeutics-inc-s-twirla-levonorgestrel-and-ethinyl-estradiol-transdermal-system-a-new-weekly-contraceptive-patch-delivering-a-30-mcg-daily-dose-of-estrogen-and-120-mcg-daily-dose-of-progestin