NIKKI

Post-LOE

drospirenone and ethinyl estradiol

Hetero

ANDAORALTABLET

Approved

May 2014

Lifecycle

Post-LOE

Competitive Pressure

30/100

Clinical Trials

Data completeness

5/8 — Partial

NIKKI (drospirenone and ethinyl estradiol) by Hetero is ovulation. Approved for symptoms of premenstrual dysphoric disorder (pmdd) in females of reproductive potential, moderate acne vulgaris in women at least 14 years of age, anxiety. First approved in 2014.

Drug data last refreshed 18h ago

$0.0BPart D

Mechanism of Action

ovulation.

Indications (3)

symptoms of premenstrual dysphoric disorder (PMDD) in females of reproductive potential moderate acne vulgaris in women at least 14 years of age

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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.

Clinical Trials (3)

NCT05985590Phase 1Completed

A Study to Investigate the Effects of BMS-986278 on Drospirenone and Ethinyl Estradiol Drug Levels in Healthy Female Participants

Started Aug 2023

37 enrolled

Healthy Volunteers

NCT00722761Phase 3Completed

Safety and Efficacy Of Drospirenone and Ethinyl Estradiol vs Placebo in the Treatment of Truncal Acne

Started Apr 2009

30 enrolled

Acne Vulgaris

NCT00722800Phase 2Terminated

A Study to Examine the Safety and Efficacy of Drospirenone and Ethinyl Estradiol (YAZ) Versus Placebo In HS

Started Oct 2008

4 enrolled

Hidradenitis Suppurativa