FDA Approves Terbinafine (Lamisil) Granules for Tinia Capitis in Kids

ROCKVILLE, Md., Oct. 2 -- The FDA has approved terbinafine oral granules (Lamisil), which can be sprinkled on food, for tinia capitis in children four years and older.

The FDA said it asked Novartis to develop a "palatable formulation" for use in children against ringworm. In response, the company developed the easy-to-swallow granules.

The approved pediatric doses, recommended for six weeks, were determined through clinical trials in children, the FDA said. The actual dosage amount will be determined by the weight of the child.

Steven Galson, M.D., M.P.H., director of the FDA's Center for Drug Evaluation and Research, said tinea capitis "is a persistent infection that is hard to treat and one that causes children embarrassment."

Oral terbinafine is approved for treatment of toenail or fingernail fungus caused by susceptible dermatophytes and topical terbinafine is approved in over-the-counter formulations for treatment of tinea pedis, tinea cruris, and tinea corporis, and in prescription formulation for tinea versicolor in adults.