FDA approves new ringworm treatment

WASHINGTON, Sept. 28 (UPI) -- The U.S. Food and Drug Administration has approved the drug Lamisil in a granular form to treat scalp ringworm in young children.

Tinea capitis is a contagious fungal condition often characterized by severe itching, dandruff and bald patches. It usually does not respond to topical treatment, the FDA said Friday in a release..

The FDA said it asked Novartis Pharmaceuticals Corporation of East Hanover, N.J., the manufacturer of Lamisil (terbinafine hydrochloride), for a formulation palatable for children. The new dosage form can be sprinkled on food. The drug can given to children aged 4 and older.

"Tinea capitis is a persistent infection that is hard to treat, and one that causes children embarrassment," said Dr. Steven Galson, director of FDA's Center for Drug Evaluation and Research. "A parent's ability to sprinkle it on the food of a child, who may not like to take medicine, should go a long way to helping ensure the infection is properly treated and to limiting its spread."

Under the Best Pharmaceuticals Children's Act of 2002, there are market exclusivity incentives to encourage drug manufacturers to conduct pediatric studies, the FDA said.

Copyright 2007 by United Press International

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