XULANE

Post-LOE

norelgestromin and ethinyl estradiol

Viatris (2)

ANDATRANSDERMALFILM, EXTENDED RELEASE

Approved

Apr 2014

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

5/8 — Partial

XULANE (norelgestromin and ethinyl estradiol) by Viatris (2) is estrogen receptor agonists [moa]. Approved for pregnancy in women with a bmi < 30 kg/m for whom combined hormonal contraceptive is appropriate. First approved in 2014.

Drug data last refreshed 18h ago

$0.0BPart D

Mechanism of Action

Estrogen Receptor Agonists

Pharmacologic Class:

Estrogen

Indications (1)

pregnancy in women with a BMI < 30 kg/m for whom combined hormonal contraceptive is appropriate

Clinical Trials (4)

NCT00511784N/ACompleted

Relative Risks for Non-fatal Venous Thromboembolism, Ischemic Stroke and Myocardial Infarction in Users of ORTHO EVRA(Norelgestromin and Ethinyl Estradiol Contraceptive Patch) Compared to Levonorgestrel-containing Oral Contraceptives.

Started Nov 2006

440 enrolled

ContraceptionFemale ContraceptionFertility Control

NCT00258063Phase 1Completed

A Study to Evaluate the Exposure of Norelgestromin and Ethinyl Estradiol From Commercial Lots of EVRA (a Transdermal Contraceptive Patch Manufactured by LOHMANN Therapie-Systeme) and CILEST (an Oral Contraceptive)

Started May 2004

60 enrolled

ContraceptionFemale Contraception

NCT00331071N/ACompleted

Postmarketing Study of ORTHO EVRA (Norelgestromin and Ethinyl Estradiol Contraceptive Patch) in Relation to Venous Thromboembolism (Blood Clots), Stroke and Heart Attacks

Started Apr 2002

334 enrolled

ContraceptionFemale Contraception

NCT00377988N/ACompleted

A Postmarketing Study of the Risk of Venous Thromboembolism (Blood Clots), Myocardial Infarction (Heart Attacks), and Stroke Among Women Using ORTHO EVRA (Norelgestromin and Ethinyl Estradiol Contraceptive Patch) Compared With Women Who Take Oral Contraceptives for Birth Control

Started Apr 2002

423 enrolled

ContraceptionFemale Contraception

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Data Sources

Drug label: DailyMed / FDA
Clinical trials: ClinicalTrials.gov
Patent data: FDA Orange Book
Spending data: CMS Medicare

The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.