Prescription medicine
Methoxsalen First approved as 8-Mop
Methoxsalen (8-Mop) is a prescription medicine with an FDA approval on record since 1954. FDA's NDC Directory lists it from 1 generic labeler.
- Generic listed
- Boxed warning
Check it at the source: the methoxsalen FDA label on DailyMed (effective June 24, 2026, Strides Pharma Science Limited); the NDA 9048 record on Drugs@FDA; every methoxsalen label on DailyMed.
Highlights of the record
FDA label of June 24, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Methoxsalen with ultraviolet (UV) radiation should be used only by physicians who have special competence in the diagnosis and treatment of psoriasis and who have special training and experience in photochemotherapy. The use of Psoralen and ultraviolet radiation therapy should be under constant supervision of such a physician. For the treatment of patients with psoriasis, photochemotherapy should be restricted to patients with severe, recalcitrant, disabling psoriasis which is not adequately responsive to other forms of therapy, and only when the diagnosis is certain. Because of the possibilities of ocular damage, aging of the skin, and skin cancer (including melanoma), the patient should be fully informed by the physician of the risks inherent in this therapy. CAUTION: Methoxsalen Capsules, USP 10 mg [Soft Gelatin Capsules]. This new dosage form of methoxsalen exhibits significantly greater bioavailability and earlier photosensitization onset time than previous methoxsalen dosage forms. Patient should be treated in accordance with the dosimetry specifically recommended for this product. The minimum phototoxic dose (MPD) and phototoxic peak time after drug administration prior to onset of photochemotherapy with this dosage form should be determined.
Used for
From the label: indications and usageIII.
Forms and strengths
- 10 mg
Liquid-filled capsule.
On the market
- Earliest approval on file
- December 3, 1954 8-Mop, Valeant Pharm Intl; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 2 first June 5, 2014; 1 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 1 of which 1 under generic applications, 0 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 1 since 2023 0 Class I among all firms' recalls; latest December 29, 2023
- FAERS reports
- 123 through July 30, 2026
What is methoxsalen used for?
From the label: indications and usageIII. INDICATIONS AND USAGE Photochemotherapy (Methoxsalen with long wave UVA radiation) is indicated for the symptomatic control of severe, recalcitrant, disabling psoriasis not adequately responsive to other forms of therapy and when the diagnosis has been supported by biopsy. Methoxsalen is intended to be administered only in conjunction with a schedule of controlled doses of long wave ultraviolet radiation.
Conditions named in the indications of methoxsalen's FDA labels, with every medicine labeled for each:
FDA pharmacologic class: Photoactivated Radical Generator and Psoralen.
Source: FDA drug label (Methoxsalen), ANDA202687 (Onesource), as published by Strides Pharma Science Limited, effective June 24, 2026 (SPL set a6ec8292-9189-4ebd-862a-e1725eb29eef), via openFDA; the full label on DailyMed
Is there a generic for methoxsalen (8-Mop)?
The FDA approved the first generic methoxsalen on June 5, 2014. 2 generic applications are approved; 1 of them carries a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists methoxsalen from 1 labeler under a generic (ANDA) application. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 1954 earliest approval on file
- 2014 first generic approved
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
Has methoxsalen been recalled?
The FDA's Enforcement Report lists 1 recall naming methoxsalen since 2023: 0 Class I (the most serious), 1 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| December 29, 2023 | Class II | Strides Pharma Inc. | Failed Dissolution Specifications |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the methoxsalen label say about other medicines?
The methoxsalen label names 3 other medicines in its interaction, contraindication or warning sections. The labels of 2 other medicines name methoxsalen. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Coal tar | warnings | L. CONCOMITANT THERAPY: Special care should be exercised in treating patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents such as anthralin, coal tar or coal tar derivatives, griseofulvin, phenothiazines, nalidixic acid, fluoroquinolone antibiotics … |
| Griseofulvin | warnings | L. CONCOMITANT THERAPY: Special care should be exercised in treating patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents such as anthralin, coal tar or coal tar derivatives, griseofulvin, phenothiazines, nalidixic acid, fluoroquinolone antibiotics … |
| Methylene blue | warnings | … salicylanilides (bacteriostatic soaps), sulfonamides, tetracyclines, thiazides and certain organic staining dyes such as methylene blue, toluidine blue, rose bengal, and methyl orange. |
Other labels that name methoxsalen
Source: FDA drug label (Methoxsalen), ANDA202687 (Onesource), as published by Strides Pharma Science Limited, effective June 24, 2026 (SPL set a6ec8292-9189-4ebd-862a-e1725eb29eef), via openFDA; the full label on DailyMed
What do FAERS reports show for methoxsalen?
The FDA Adverse Event Reporting System holds 123 reports that list methoxsalen among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 6 are coded as a death and 30 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.
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as methoxsalen?
4 other medicines are given the same way (oral) and in the same FDA class as methoxsalen or labeled mainly for the same use (psoriasis), the same class first. Psoriasis lists all 38 medicines labeled for it, by any route. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Acitretin | Psoriasis | 8 labelers | $2.59 per capsule 10 mg capsule | No current entry |
| Apremilast | Psoriasis | none listed | $90.57 per tablet 30 mg tablet | No current entry |
| Deucravacitinib | Psoriasis | none listed | n/a | No current entry |
| Icotrokinra | Psoriasis | none listed | n/a | No current entry |
Every medicine labeled for the same conditions as methoxsalen
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to methoxsalen
- 4 medicines for the same use
- Other photoactivated radical generators
- the pharmacologic class, with prices and generics
- Methoxsalen side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other