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.
Valeant Pharmaceuticals International, Inc.