PERRIGO RECEIVES TENTATIVE APPROVAL FOR NAIL INFECTION TREATMENT

Perrigo announced that it has been granted tentative approval from the FDA for its abbreviated new drug application for ciclopirox topical solution, 8 percent. Final approval is subject to the expiration of the applicable period of patent protection for the reference-listed drug, sanofi-aventis' Penlac Nail Lacquer. The patent will expire next fall.

The drug is indicated for the treatment of mild to moderate fungal infections of the fingernails and toenails and had sales of $125 million for the 10 months ending in August, according to Wolters Kluwer data.

Perrigo is the world's largest manufacturer of over-the-counter pharmaceutical products for the store brand market, according to the company. It also develops, manufactures and markets prescription generic drugs, active pharmaceutical ingredients and consumer products.