Skip to main content

twirla

Generic: ethinyl estradiol and levonorgestrel

twirla: developed by 2 companies · 1 FDA decision.

twirla evidence translation

What we can confirm

1 FDA record

What it means

More than one developer is source-backed. Until you choose one, AI stays drug-only and does not guess ownership.

What to watch

Watch for new trials or company disclosures after the FDA record.
BioSniper AIPage evidence connected

Prepared research question

What is verified about twirla, and what remains unknown?

Run cited research

Traceable citations · Unknowns marked

See linked entities and source evidence2 indications · 0 study sponsors

Related indications

contraception for use in women of reproductive potential with a body mass index ("BMI") < 30 kg/m2Contraception

Study sponsors

No additional listed-company sponsor is linked.

Development Pipeline (2)
CompanyPhase
AGILE THERAPEUTICS INC (AGRX)
contraception for use in women of reproductive potential wit…
Approved
Corium International, Inc. (CORI)
Contraception
Phase 3
FDA Decisions1 records
Approval1 INDICATIONS AND USAGE 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 [see Use in Specific Populations ( 8.9 ) and Clinical Studies ( 14 )] . TWIRLA is contraindicated in women with a BMI ≥ 30 kg/m 2 [see Contraindications ( 4 )] . TWIRLA is a comb(AGRX)FDA ↗
NDA204017Type 3 - New Dosage FormStandardOtherSystem

Frequently asked questions

Who is developing twirla?

twirla is being developed by AGILE THERAPEUTICS INC, Corium International, Inc..

What is twirla's latest FDA decision?

The most recent tracked FDA decision for twirla is Approval for 1 INDICATIONS AND USAGE 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 [see Use in Specific Populations ( 8.9 ) and Clinical Studies ( 14 )] . TWIRLA is contraindicated in women with a BMI ≥ 30 kg/m 2 [see Contraindications ( 4 )] . TWIRLA is a comb, dated February 14, 2020.