Provayblue

Treats acquired methemoglobinemia. NDA 204630, held by Provepharm Sas. Methylene Blue.

As of Nov 13, 2026, NDA 204630 (Provayblue), held by Provepharm Sas, was first approved by FDA on Apr 8, 2016, with 12 approved supplements and 0 published complete response letters.

First approved: Apr 8, 2016
Review: Standard
Supplements approved: 12
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

PROVAYBLUE is indicated for the treatment of pediatric and adult patients with acquired methemoglobinemia.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 13 submissions below


Jan 8, 2024	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Label
Apr 8, 2016	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Letter Label

Products

2 strengths and forms


Provayblue50MG/10ML (5MG/ML) · solution;intravenous	Methylene Blue	RxReference drug
Provayblue10MG/2ML (5MG/ML) · solution;intravenous	Methylene Blue	RxReference drug

All 13 submissions, including labeling and manufacturing supplements


Dec 2, 2024	Supplement 26Labeling · Standard review	Approved	Label Letter
Feb 5, 2024	Supplement 23Labeling · Standard review	Approved	Review Label Letter
Jan 8, 2024	Supplement 21Efficacy (new indication or use) · Standard review	Approved	Label
Nov 2, 2023	Supplement 22Labeling · Standard review	Approved	Letter Label
Aug 18, 2022	Supplement 18Labeling · Standard review	Approved	Letter Letter Label
Jul 13, 2022	Supplement 16Manufacturing	Approved	Label Letter
Dec 3, 2021	Supplement 8Manufacturing	Approved	Letter Label
May 26, 2021	Supplement 11Labeling · Standard review	Approved	Label Letter
May 21, 2021	Supplement 10Labeling · Standard review	Approved	Letter
May 21, 2018	Supplement 6Labeling · Standard review	Approved	Letter Label
Dec 29, 2017	Supplement 5Labeling · Standard review	Approved	Label Letter
Nov 29, 2016	Supplement 2Manufacturing · Standard review	Approved	None posted
Apr 8, 2016	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 204630
Drugs@FDA: Overview at FDA
Company: Provepharm Inc.

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