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FDA Approves Shampoo to Treat Seborrheic Dermatitis

Kate Traynor

Medicis Pharmaceutical Corp. announced Monday that the Food and Drug Administration (FDA) approved the marketing of Loprox Shampoo, the latest addition to the company's line of antifungal products with the active ingredient ciclopirox.

Loprox shampoo, containing 1 percent ciclopirox, is indicated for the treatment of seborrheic dermatitis of the scalp. According to the company, the new product is the first prescription antifungal shampoo to earn FDA's marketing approval for this indication.

The shampoo will be provided in 120-mL containers. Medicis estimated it will be able to ship the product to wholesalers within the next several months. These initial shipments, the company said, will be followed by deliveries of product samples to physicians.

In addition to the new formulation, the Loprox line consists of three products—a topical cream, gel, and lotion, each containing 0.77 percent ciclopirox. The labeling for these formulations cautions against eye contact with the product.

Libby Ivy, executive director of investor relations for Medicis, said the company expects to receive the final FDA-approved version of the product labeling for the shampoo within a few days.