What is DROSPIRENONE AND ESTRADIOL used for?

DROSPIRENONE AND ESTRADIOL is an FDA-approved medication. See full prescribing information for approved uses.

Is DROSPIRENONE AND ESTRADIOL FDA approved?

Yes, DROSPIRENONE AND ESTRADIOL is FDA approved (first approved 2025-10-28) and manufactured by NOVAST LABS.

Who makes DROSPIRENONE AND ESTRADIOL?

DROSPIRENONE AND ESTRADIOL is manufactured by NOVAST LABS.

Data updated: Nov 8, 2026

DROSPIRENONE AND ESTRADIOL (drospirenone) · NOVAST LABS

Women's Health Approved 2025-10-28

FDA label not available. This product's label is not in FDA's label database (openFDA, DailyMed). Search DailyMed → · Drugs@FDA approval documents →

Jump to: Indications Approvals Trials Competitors Safety Patents

Indication

Phase 3 Trials

Years on Market

Details

Status: Prescription
First Approved: 2025-10-28
Routes: ORAL
Dosage Forms: TABLET

Companies

NOVAST LABS

Active Ingredient: DROSPIRENONE , ESTRADIOL

DROSPIRENONE AND ESTRADIOL Approval History

2026

Original

New Indication

New Form

Label Update

2 FDA actions from 2025 to 2026

Oct 2026 SUPPL

Label · Labeling

Oct 2025 ORIGINAL

Update

What DROSPIRENONE AND ESTRADIOL Treats

1 FDA approvals

Originally approved for its first indication in 2025 .

Other (1)

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Clinical Trial Registry

6 trials

Trial	Sponsor ID	Phase	Status	Title
NCT07340190	CDAK539A12102 2025-521000-22-00, 2025	Ph 1	recruiting	A Drug-drug Interaction Study to Evaluate the Effects of Pelabresib on the Pharmacokinetics of Repaglinide, Midazolam, and Combined Oral Contraceptive in Patients With Advanced Malignancies
NCT06345560	077766	Ph 1, Ph 2	recruiting	Pharmacokinetics of Drospirenone Only Pills: A Pre- and Post-Bariatric Surgery Study
NCT07293728	STUDY00028768	Ph 4	not yet recruiting	A Randomized Feasibility Trial Comparing Drospirenone and Norethindrone for Postpartum Hypertension Management in Preeclampsia
NCT05461573	CF113-303	Ph 3	completed	Efficacy, Safety, and Tolerability of LPRI-CF113 as an Oral Contraceptive in Females
NCT05706753	CR109284 2022-002828-12, 70033093THR1009	Ph 1	completed	A Study of Milvexian in Healthy Adult Females
NCT06039826	18533 J1I-MC-GZBV	Ph 1	completed	A Study of LY3437943 in Postmenopausal Female Participants Who Are Overweight or Obese

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Active Pipeline

Pro

Ongoing clinical trials by development phase

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Key Completed Trials

Pro

Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

| Show all trials (incl. adjuvant)

Understanding FDA Approval Types

Count	Type	What it means
-	ORIG	Original approval - drug first enters market
-	SUPPL - Efficacy	New indication (new disease/condition approved)
-	SUPPL - Labeling	Label text changes (warnings, dosing updates)
-	SUPPL - Manufacturing	Production changes (new facility)
-	SUPPL - Chemistry	Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

DROSPIRENONE AND ESTRADIOL FDA Label Details

FDA label not available. This product's label is not in FDA's label database (openFDA, DailyMed). Search DailyMed → · Drugs@FDA approval documents →

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Data Sources

FDA Approval: ANDA218031 → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.