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FDA approves Anacor’s antifungal solution
PALO ALTO, Calif. — Anacor Pharmaceuticals announced that the Food and Drug Administration has approved the company's new drug application for Kerydin (tavaborole) topical solution, 5% — an antifungal approved for the topical treatment of onychomycosis of the toenails.
"We are pleased to announce the FDA approval of Kerydin, which provides an important new topical treatment option for the millions of people in the United States who are infected with onychomycosis of the toenails," said Paul Berns, CEO Anacor Pharmaceuticals. "We expect to launch Kerydin in the United States, either alone or with a partner, as early as the end of this quarter."
Kerydin is clear and colorless. The alcohol-based solution is applied with a dropper to the infected toenail once daily for 48 weeks. Because of its topical application, the company said that the drug has not demonstrated any systemic side effects.
"Onychomycosis is one of the most common diseases diagnosed and treated by podiatrists. Historically, a large number of patients with onychomycosis would choose not to treat their infection," said Warren Joseph, D.P.M., lower extremity infectious diseases consultant at Roxborough Memorial Hospital in Philadelphia. "With the approval of KERYDIN, physicians can now offer patients a safe, effective and easy-to-use topical treatment for their onychomycosis of the toenail, which I think will be well-received by patients."