Vybrique

Treats erectile dysfunction. NDA 210858, held by Ibsa. Sildenafil Citrate.

As of Nov 14, 2026, NDA 210858 (Vybrique), held by Ibsa, was first approved by FDA on Dec 16, 2025, with 0 approved supplements and 0 published complete response letters.

First approved: Dec 16, 2025
Review: Standard
Supplements approved: 0
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

1. INDICATION S AND USAGE VYBRIQUE TM is indicated for the treatment of erectile dysfunction. VYBRIQUE is a phosphodiesterase-5 (PDE5) inhibitor

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first

Date	Submission	Status	Documents
Dec 16, 2025	Original applicationNew dosage form · Standard review	Approved	Label

Products

4 strengths and forms


VybriqueEQ 25MG BASE · film;oral	Sildenafil Citrate	RxReference drug
VybriqueEQ 50MG BASE · film;oral	Sildenafil Citrate	RxReference drug
VybriqueEQ 75MG BASE · film;oral	Sildenafil Citrate	RxReference drug
VybriqueEQ 100MG BASE · film;oral	Sildenafil Citrate	RxReference drug

Identifiers

Application: NDA 210858
Drugs@FDA: Overview at FDA
Company: IBSA Institut Biochimique SA

Approvals, supplements, products and documents come from FDA's Drugs@FDA data files, refreshed daily; Drugs@FDA lists approved applications only. Complete response letters are FDA's published letters. Drugs@FDA and FDA complete response letters