Prescription medicine
Polidocanol Brand names: Varithena, Asclera
Polidocanol (Asclera) is a prescription medicine with an FDA approval on record since 2010. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the polidocanol FDA label on DailyMed (effective August 7, 2026, Boston Scientific Corporation); the NDA 21201 record on Drugs@FDA; every polidocanol label on DailyMed.
Highlights of the record
FDA label of August 7, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageVARITHENA (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.
Forms and strengths
- 0.005 g/ml
- 0.01 g/ml
Kit; injection (solution).
On the market
- Earliest approval on file
- March 30, 2010 Asclera, Chemisch Fbrk Krsslr; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 2 of which 0 under generic applications, 2 under brand applications, repackagers included
- Last listed patent
- May 12, 2032 Varithena injection; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2013 0 Class I among all firms' recalls; latest September 7, 2016; 5 more by firms not listed as its makers
- FAERS reports
- 1,382 through July 30, 2026
What is polidocanol used for?
From the label: indications and usageVARITHENA (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. VARITHENA (polidocanol injectable foam) is a sclerosing agent 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. […]
FDA pharmacologic class: Sclerosing Agent.
Source: FDA drug label (Varithena), Boston Scientific Corporation, effective August 7, 2026 (SPL set dfd6b4a0-b0dc-11e2-9e96-0800200c9a66), via openFDA; the full label on DailyMed
Is there a generic for polidocanol (Asclera)?
No generic polidocanol is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists no patent for Asclera injection; a patent listed only for Varithena injection runs to May 12, 2032. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2010 earliest approval on file
- 2032 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has polidocanol been recalled?
The FDA's Enforcement Report lists 6 recalls naming polidocanol since 2013: 0 Class I (the most serious), 5 Class II, 1 Class III; 1 still ongoing. 5 of them are by firms that FDA's NDC Directory does not list as a maker of polidocanol and that hold no application for it in Drugs@FDA, such as compounding pharmacies or bulk-ingredient suppliers; the recall notice names the product recalled. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 22, 2022 | Class II | Pharmacy Innovations not a listed maker | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. |
| September 7, 2016 | Class III | Biocompatibles U.K., Ltd. | Defective Delivery System: Incorrect type of syringe found in commercially distributed administration pack |
| November 14, 2014 | Class II | Attix Pharmaceuticals not a listed maker | Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were … |
| October 19, 2013 | Class II | Specialty Medicine Compounding Pharmacy not a listed maker | Lack of Assurance of Sterility: All unexpired sterile compounded human and veterinary products are being recalled because they were compounded in the same … |
| May 29, 2013 | Class II | Lowlite Investments, Inc. D/B/A Olympia Pharmacy not a listed maker | Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality control processes |
| April 10, 2013 | Class II | FVS Holdings, Inc. dba. Green Valley Drugs not a listed maker | Lack of Assurance of Sterility: all sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What do FAERS reports show for polidocanol?
The FDA Adverse Event Reporting System holds 1,382 reports that list polidocanol among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 15 are coded as a death and 137 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other sclerosing agents
- the pharmacologic class, with prices and generics
- Polidocanol side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other