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FDA Approves Additional Manufacturer of Methoxsalen
Date:2/15/2012

BRIDGEWATER, N.J., Feb. 15, 2012 /PRNewswire/ -- The FDA has approved the addition of a secondary supplier of Methoxsalen USP, an integral component of a treatment for the relief of moderate to severe psoriasis prescribed under the brand name Oxsoralen-Ultra® (methoxsalen) Capsules, USP, 10mg. 

"We are pleased to obtain FDA approval of an additional manufacturer of Methoxsalen, the key active ingredient for this important drug," said David Mullarkey, senior vice president and general manager of Valeant Dermatology, a division of Valeant Pharmaceuticals North America LLC. "This approval enables us to ensure a steady supply of Oxsoralen-Ultra and is a key step in restoring the supply of our other Methoxsalen containing drug products."

Patients can obtain Oxsoralen-Ultra® with a prescription from their physician.  Oxsoralen-Ultra, in combination with a special type of phototherapy called PUVA (Psoralen plus UVA light) therapy, has been shown to improve severe, recalcitrant, disabling psoriasis.(1)

If you have any questions or concerns about product availability, please contact the Valeant Customer Care group at 1-800-556-1937 or pharmcs@valeant.com.

INDICATION AND IMPORTANT SAFETY INFORMATION

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.

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.

Oxsoralen-Ultra® is contraindicated in patients exhibiting idiosyncratic reactions to psoralen compounds. Patients possessing a specific history of light sensitive disease states should not initiate methoxsalen therapy except under special circumstances. Diseases associated with photosensitivity include lupus erythematosus, porphyria cutanea tarda, erythropoietic protoporphyria, variegate porphyria, xeroderma pigmentosum, and albinism.  It is also contraindicated in patients with melanoma or with a history of melanoma, invasive squamous cell carcinomas, and aphakia, because of the significantly increased risk of retinal damage due to the absence of lenses. Patients with these conditions should not use Oxsoralen-Ultra®. 

Serious burns from either UVA or sunlight (even through window glass) can result if the recommended dosage of the drug and/or exposure schedules are exceeded.

Special care should be exercised in treating patients who are receiving concomitant therapy (either topically or systemically) with known photosensitizing agents.

The most commonly reported side effect of methoxsalen alone is nausea, which occurs in approximately 10% of all patients. Other side effects include nervousness, insomnia and depression.

The most common side effects reported for combined therapy of methoxsalen and UVA include pruritus (approximately 10% of all patients) and erythema. Other side effects include edema, dizziness, headache, malaise, depression, hypopigmentation, vesiculation and bullae formation, non-specific rash, herpes simplex, miliaria, urticaria, folliculitis, gastrointestinal disturbances, cutaneous tenderness, leg cramps, hypotension, and extension of psoriasis.

Please see enclosed Full Prescribing Information. 

About Valeant

Valeant Pharmaceuticals International, Inc. (NYSE/TSX:VRX) is a multinational specialty pharmaceutical company that develops and markets a broad range of pharmaceutical products primarily in the areas of neurology, dermatology and branded generics. More information about Valeant can be found at www.valeant.com.

 Full prescribing information for Oxsoralen-Ultra® can be found at www.oxsoralen-ultra.com.

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 1 Oxsoralen-Ultra® Full Prescribing Information – Package Insert

 


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SOURCE Valeant Pharmaceuticals International, Inc.
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