Metvixia

NDA 21415, held by Galderma Labs LP. Methyl Aminolevulinate Hydrochloride.

As of Nov 14, 2026, NDA 21415 (Metvixia), held by Galderma Labs LP, was first approved by FDA on Jul 27, 2004, with 3 approved supplements and 0 published complete response letters.

First approved: Jul 27, 2004
Review: Standard
Supplements approved: 3
Complete response letters: 0

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 4 submissions below


Jun 26, 2008	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label
Jul 27, 2004	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Products

1 strengths and forms

Product	Active ingredient	Marketing
MetvixiaEQ 16.8% BASE · cream;topical	Methyl Aminolevulinate Hydrochloride	Discontinued

All 4 submissions, including labeling and manufacturing supplements


Nov 20, 2012	Supplement 4Labeling · Standard review	Approved	Label Letter
Jun 26, 2008	Supplement 3Efficacy (new indication or use) · Standard review	Approved	Letter Label
May 31, 2005	Supplement 1Labeling · Standard review	Approved	Letter Label
Jul 27, 2004	Original applicationNew dosage form · Standard review	Approved	Review Letter Label

Identifiers

Application: NDA 21415
Drugs@FDA: Overview at FDA
Company: Galderma Laboratories

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