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FDA Actions

FDA Actions

The FDA has approved a new topical treatment for the treatment of post-herpetic neuralgia (PHN). The capsaicin 8% patch must be applied to the skin by a health care professional since placement may be quite painful, requiring the use of a local topical anesthetic. The patch is applied for one hour during which patients must be monitored, including observation for increases in blood pressure. The patches may be cut to conform to the area of pain and up to 4 patches may be used. The one-hour application is reported to provide up to 12 weeks of reduced pain from PHN. The capsaicin 8% patch will be manufactured by Lohmann Therapie-Systems and distributed by NeurogesX as Qutenza™.

The FDA has approved romidepsin for the treatment of cutaneous T-cell lymphoma in patients who received at least one prior systemic therapy. The drug is a histone deacetylase inhibitor, the first of a new class of antineoplastics. Romidepsin will be marketed as Istodax® by Gloucester Pharmaceuticals.