FDA Approval Activities for this Drug…

Oxsoralen-Ultra (methoxsalen), USP, Capsules, 10 mg, ICN NDA 19-600/S-006 & S-009 UVADEX (methosalen) Sterile Solution, 20 mcg/mL, Therakos, NDA 20-969 2/25/99 3/2/99 3/2/99 6/14/99 UVADEX Indication:This new drug application provides for the use of UVADEX® (methoxsalen) Sterile Solution with the UVAR® Photopheresis System in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) that is unresponsive to other forms of treatment. METHOXSALEN Capsule; 10MG 8-MOP ICN 019600 METHOXSALEN Capsule; 10MG OXSORALEN-ULTRA ICN 020969 METHOXSALEN Injection 0.02MG/ML UVADEX THERAKOS 009048 METHOXSALEN Lotion; Topical 1% OXSORALEN ICN

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