Valeant Pharmaceuticals International Resumes Shipment of Oxsoralen-Ultra(R)
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.
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.
About Oxsoralen-Ultra
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.
Important Safety Information
CAUTION: METHOXSALEN IS A POTENT DRUG. READ ENTIRE BROCHURE PRIOR TO PRESCRIBING OR DISPENSING THIS MEDICATION.
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.
About Valeant
Valeant Pharmaceuticals International (NYSE:VRX - News) 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. More information about Valeant can be found at www.valeant.com.
Oxsoralen-Ultra is a registered trademark of Valeant Pharmaceuticals International or its related companies. For information on Oxsoralen-Ultra visit www.oxsoralen-ultra.com.
FORWARD-LOOKING STATEMENTS
This press release may contain forward-looking statements, including, but not limited to, statements regarding the timing of when Oxsoralen-Ultra is expected to be available to patients and pharmacies. Forward-looking statements may be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "will," "believes," "estimates," "potential," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, risks and uncertainties discussed in the company's most recent annual or quarterly report filed with the Securities and Exchange Commission, which factors are incorporated herein by reference. Readers are cautioned not to place undue reliance on any of these forward-looking statements. Valeant undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this press release or to reflect actual outcomes.
Contact:
Laurie W. Little Valeant Pharmaceuticals 949-461-6002 laurie.little@valeant.com