FDA Approves Ciclopirox Solution For Treatment Of Fingernails' Fungal Infections
Ciclopirox Topical Solution
The Perrigo Company has received final approval from FDA to manufacture and market Ciclopirox Topical Solution, 8% (Nail Lacquer). Shipments will begin immediately.
The product has been determined to be therapeutically equivalent (AT) to Sanofi Aventis US, LLC's Penlac Nail Lacquer, indicated for the treatment of mild to moderate fungal infections of the fingernails and toenails. According to Wolters Kluwer data, brand sales for the last 12 months ending August, 2007 were $92 million.
Perrigo Company is a leading global healthcare supplier that develops, manufactures and distributes over-the-counter (OTC) and prescription pharmaceuticals, nutritional products, active pharmaceutical ingredients (API) and consumer products. The Company is the world's largest manufacturer of OTC pharmaceutical products for the store brand market. The Company's primary markets and locations of manufacturing facilities are the United States, Israel, Mexico and the United Kingdom.