Medicis announces FDA approval of Loprox shampoo
Medicis announces FDA approval of Loprox shampoo
SCOTTSDALE, ARIZ., March 3, 2003 -- Medicis announced it has received approval of its New Drug Application from the FDA to market its new Loprox Shampoo (ciclopirox) 1%. Loprox Shampoo is the first and only prescription antifungal shampoo approved in the United States for the treatment of seborrheic dermatitis of the scalp, a common fungal infection.
Loprox Shampoo will have market exclusivity for a three-year period and is the subject of a pending patent application, which, if granted, could extend product exclusivity significantly. FDA approval of Loprox Shampoo obligates Medicis to pay to Aventis $5 million, representing the Company's last financial obligation to Aventis under terms of the Loprox transaction announced in fiscal year 1999. The Company expects to amortize this payment over a period of time consistent with the Loprox family of products.
Loprox Shampoo formulation is the most recent innovation to the Loprox family of antifungal products. The brand is the number one prescribed topical antifungal therapy in the specialties of dermatology and podiatry.
Loprox Shampoo is a prescription product and is available in a 120 ml size (NDC #99207-010-10). The Company expects product supply to be available within the next several months for shipping to wholesalers and anticipates promotion and sample distribution of Loprox Shampoo to physicians soon thereafter.
Seborrheic dermatitis is a common, chronic skin condition affecting approximately eight million Americans. Skin lesions caused by seborrheic dermatitis are typically located in areas abundant with sebum-producing glands including the scalp, face and upper trunk. Seborrheic dermatitis of the scalp is a common fungal infection characterized by inflammation, itching, and greasy scaling. This condition affects about 3% of the general population and can worsen if left untreated.
Medicis says Loprox Shampoo is an effective delivery system to treat seborrheic dermatitis of the scalp. A small percentage of people may experience side effects such as rash or other discomfort around the scalp.
Source: Medicis
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