Varithena

Treats incompetent great saphenous veins, accessory saphenous veins, and visible…. NDA 205098, held by Boston. Polidocanol.

As of Nov 13, 2026, NDA 205098 (Varithena), held by Boston, was first approved by FDA on Nov 25, 2013, with 18 approved supplements and 0 published complete response letters.

First approved: Nov 25, 2013
Review: Standard
Supplements approved: 18
Complete response letters: 0

What It's For

From the FDA-approved label (Indications and Usage)

VARITHENA (polidocanol injectable foam) is indicated for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein (GSV) system above and below the knee. VARITHENA improves the symptoms of superficial venous incompetence and the appearance of visible varicosities.

Full prescribing information on DailyMed ↗

Approvals and New Uses

The original application and every efficacy supplement, newest first; all 19 submissions below

Date	Submission	Status	Documents
Nov 25, 2013	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Letter Label

Products

2 strengths and forms


Varithena180MG/18ML (10MG/ML) · solution;intravenous	Polidocanol	RxReference drug
Varithena77.5MG/7.75ML (10MG/ML) · solution;intravenous	Polidocanol	DiscontinuedReference drug

All 19 submissions, including labeling and manufacturing supplements


Sep 23, 2025	Supplement 51Manufacturing	Approved	Label Letter
Aug 21, 2019	Supplement 31Labeling · Standard review	Approved	Letter Label
Dec 21, 2017	Supplement 26Labeling · Standard review	Approved	Label Letter
Jun 23, 2016	Supplement 18Labeling · Standard review	Approved	Label Letter
Jun 17, 2016	Supplement 17Manufacturing · Standard review	Approved	None posted
Apr 18, 2016	Supplement 16Manufacturing · Standard review	Approved	None posted
Mar 4, 2016	Supplement 13Manufacturing · Standard review	Approved	None posted
Jan 21, 2016	Supplement 14Manufacturing · Standard review	Approved	None posted
Nov 20, 2015	Supplement 12Manufacturing · Standard review	Approved	None posted
Aug 6, 2015	Supplement 10Manufacturing · Standard review	Approved	None posted
Jun 2, 2015	Supplement 8Manufacturing · Standard review	Approved	None posted
May 11, 2015	Supplement 9Manufacturing · Standard review	Approved	None posted
Apr 23, 2015	Supplement 7Manufacturing · Standard review	Approved	None posted
Jan 20, 2015	Supplement 6Manufacturing · Standard review	Approved	None posted
Jan 8, 2015	Supplement 5Labeling · Standard review	Approved	Label Letter
Dec 11, 2014	Supplement 4Manufacturing · Standard review	Approved	None posted
Sep 16, 2014	Supplement 2Manufacturing · Standard review	Approved	None posted
Jun 26, 2014	Supplement 1Manufacturing · Standard review	Approved	Label Letter
Nov 25, 2013	Original applicationNew formulation or manufacturer · Standard review	Approved	Review Summary Review Letter Label

Identifiers

Application: NDA 205098
Drugs@FDA: Overview at FDA
Company: Boston

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