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Pharmaceuticals / Regulatory Affairs / Submissions and Approvals

FDA Approves BTG’s Varicose Vein Foam

Nov. 27, 2013

London-based drugmaker BTG said Nov. 26 that its foam-based treatment for varicose veins, Varithena, has been approved by the FDA.

The injectable drug comes in a canister also containing a mixture of oxygen and carbon dioxide. For the drug to work, patients wear a compression stocking while Varithena’s (polidacanol injectable foam) sclerosing agent and natural heat cause the vein to collapse, according to BTG.

“Varithena takes away the need for sedation, anesthesia, ablation and stripping and replaces it with one simple injection of a foam, so it’s a patient-friendly treatment and it is rapid,” spokesman Andy Burns told Drug Daily Bulletin.

BTG plans to make Varithena available in the second quarter of 2014, with future plans to market the device in Canada, Brazil and Australia. — Lena Freund

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