Regulatory Affairs

Valeant receives approval for secondary supplier of Methoxsalen

PBR Staff Writer Published 16 February 2012

Valeant Pharmaceuticals has announced the FDA approval of an additional manufacturer of Methoxsalen USP, an integral component of a treatment for the relief of moderate to severe psoriasis.

It is prescribed under the brand name Oxsoralen-Ultra (methoxsalen) Capsules, USP, 10mg.

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, the company said.

Valeant Dermatology senior vice president and general manager David Mullarkey said the approval enables them to ensure a steady supply of Oxsoralen-Ultra.