Valeant Pharmaceuticals International announced that Oxsoralen-Ultra, its therapy for severe psoriasis, is now available again in the United States on a limited supply basis.
Since last year, Valeant has experienced a shortage of Oxsoralen products due to an unanticipated change in the supplier of the product's active ingredient.
"Valeant understands the importance of Oxsoralen-Ultra to patients suffering from psoriasis, and we have been working diligently in partnership with the FDA to address the drug shortage," said Rajiv De Silva, chief operating officer of specialty pharmaceuticals. "We are pleased to be able to begin re-supplying Oxsoralen-Ultra to physicians and their patients on a limited basis and apologize for any issues this shortage has caused. Valeant is committed to promptly getting this product back on pharmacy shelves."
Patients can obtain Oxsoralen-Ultra (Methoxsalen Capsules, USP, 10mg) with a prescription through their local pharmacies who will work with their wholesalers to arrange for shipment.
Oxsoralen-Ultra (Methoxsalen Capsules, USP, 10mg) is used for the treatment of severe psoriasis and is used along with ultraviolet light radiation. 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. Studies further show that it can lead to extended remissions lasting from months to years.
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.
Valeant Pharmaceuticals International is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of neurology and dermatology.