UVADEX Solution for injection Ref.[11072] Active ingredients: Methoxsalen

Source: FDA, National Drug Code (US)  Revision Year: 2021 

Product description

Methoxsalen is a naturally occurring photoactive substance found in the seeds of the Ammi majus (Umbelliferae) plant. It belongs to a group of compounds known as psoralens or furocoumarins. The chemical name of methoxsalen is 9-methoxy-7H-furo[3,2-g]1-benzopyran-7-one; it has the following structure:

Each mL of UVADEX (methoxsalen, 8-methoxypsoralen) Sterile Solution contains methoxsalen 20 mcg, propylene glycol 50 mg, sodium chloride 8 mg, sodium acetate 1.75 mg, ethanol 40.550 mg, glacial acetic acid 1.260 mg, and Water for Injection q.s. to 1.0 mL. Glacial acetic acid and sodium hydroxide are used to adjust the pH of the solution if necessary. UVADEX is a clear, colorless to pale yellow liquid.

UVADEX is used in combination with the THERAKOS CELLEX Photopheresis System to extracorporeally treat leukocyte enriched buffy coat.

How Supplied

UVADEX (methoxsalen) Sterile Solution 20 mcg/mL in 10 mL amber glass vials (NDC 64067-216-01), and cartons of 12 vials (NDC 64067-216-01). One vial of 10 mL contains 200 micrograms methoxsalen.

Manufactured by Patheon Manufacturing Services LLC, Greenville, NC 27834
For Therakos, Inc., Bedminster, NJ 07921

Drugs

Drug Countries
UVADEX Austria, Australia, Canada, France, Poland, Turkey, United Kingdom, United States

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