Taro Pharmaceutical Industries Ltd has received tentative approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for Ciclopirox topical solution, 8 per cent (Nail Lacquer) (ciclopirox nail lacquer).
Ciclopirox nail lacquer is a prescription pharmaceutical product used for the topical treatment of fungal infections of the fingernails and toenails (onychomycosis). The FDA has determined that Taro's ciclopirox nail lacquer is safe and effective for use when compared with the reference listed drug product, Penlac Nail Lacquer (ciclopirox) topical solution, 8 per cent, of sanofi-aventis Pharmaceuticals US According to industry sources, Penlac Nail Lacquer has annual US sales of approximately $88 million.
Taro manufactures and markets a broad line of prescription and over-the-counter antifungal products.
The tentative ANDA approval for Taro's ciclopirox nail lacquer is an FDA determination that Taro's ANDA submission for this product currently satisfies the substantive requirements for approval, subject to the expiration of all relevant patents or statutorily imposed exclusivities and restrictions (currently expected to occur during September 2007), or any new information that may come to the FDA's attention. Tentative approvals do not grant marketing rights; a company may only market a product upon receiving final approval for an ANDA submission.
Taro Pharmaceutical Industries Ltd. is a multinational, science-based pharmaceutical company dedicated to meeting the needs of its customers through the discovery, development, manufacturing and marketing of the highest quality healthcare products.