Oxsoralen® Supply Status Update (as of June 18, 2010)

Oxsoralen-Ultra (Methoxsalen Capsules, USP, 10mg) is now available again in the United States on a limited supply basis.  Valeant recognizes the importance of this drug to you and your patients and has been working diligently in partnership with the FDA to address the drug shortage.  We are pleased to resume shipments, and Oxsoralen-Ultra (Methoxsalen Capsules, USP, 10mg) can be obtained for your patients through pharmacies.  Please instruct the pharmacy to work with their wholesalers to arrange for shipment.  If you have any questions or concerns about product availability, please contact our Customer Care group at 1-800-556-1937 or pharmcs@valeant.com

For many patients with moderate to severe psoriasis, the answer is PUVA therapy, a well-known system of phototherapy and Oxsoralen-Ultra® (Methoxsalen Capsules, USP, 10mg). PUVA is an acronym for Psoralen plus UVA light and is a special type of phototherapy that combines the use of the drug Oxsoralen-Ultra® with exposure of the skin to UVA (ultraviolet A) light. Oxsoralen-Ultra® capsules make the skin more sensitive to light

Studies show that UVA therapy with Oxsoralen-Ultra® effectively clears or improves severe, recalcitrant, disabling psoriasis in 84% of the patients who undergo this therapy.1 Studies further show that it can lead to extended remissions lasting from months to years. It's also reassuring to know that PUVA therapy has been monitored for long-term clinical safety in the treatment of psoriasis.2

Safe and effective treatment of psoriasis. That's the promise of UVA therapy with Oxsoralen-Ultra®. While it is not known how to cure psoriasis, however we do know one very encouraging thing: many patients can successfully manage the disease with UVA therapy in combination with Oxsoralen-Ultra®.

An overview of Oxsoralen-Ultra®

(Methoxsalen Capsules, USP, 10mg)

Oxsoralen-Ultra® (Methoxsalen Capsules, USP, 10mg) is composed of methoxsalen, a naturally occurring photoactive substance found in the seeds of the Ammi majus plant and in the roots of Heracleum Candicans. It belongs to a group of compounds known as psoralens. Psoralens are usually taken orally. Oxsoralen-Ultra® comes in a liquid-filled soft gelatin capsule form.3,14

(Methoxsalen Capsules, USP, 10mg)

Rx only

Methoxsalen with 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: Oxsoralen-Ultra® (Methoxsalen Soft Gelatin Capsules) should not be used interchangeably with regular Oxsoralen® or 8-MOP® (Methoxsalen Hard Gelatin Capsules). This new dosage form of methoxsalen exhibits significantly greater bioavailability and earlier photosensitization onset time than previous methoxsalen dosage forms. Patients 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.