Medical Patent Law Weekly
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Drug Development
Taro Receives Tentative Approval for Ciclopirox Topical Solution, 8% (Nail Lacquer) ANDA
April 11th, 2007
Taro Pharmaceutical Industries Ltd. ("Taro," Pink Sheets: TAROF) reported today that it has received tentative approval from the U.S. Food and Drug Administration ("FDA") for its Abbreviated New Drug Application ("ANDA") for Ciclopirox Topical Solution, 8% (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(R) Nail Lacquer (ciclopirox) Topical Solution, 8%, of...
Source: Medical Patent Law Weekly (2007-04-11)
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