The U.S. Food and Drug Administration announced the approval of Lamisil Oral Granules for the treatment of tinea capitis, a fungal infection of the scalp, in children ages 4 years and older.
Tinea capitis most commonly affects children and is often characterized by severe itching, dandruff and bald patches. It is a persistent and contagious fungal infection that usually does not respond to topical treatment.
"Tinea capitis is a persistent infection that is hard to treat, and one that causes children embarrassment," said Steven Galson, M.D., M.P.H., 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."
The FDA, in a pediatric written request, approached Novartis Pharmaceuticals Corporation of East Hanover, N.J., the manufacturer of Lamisil (terbinafine hydrochloride), for a formulation palatable for children. The company formulated the new dosage form, granules, which can be sprinkled on food.
Under the Best Pharmaceuticals Children's Act of 2002, there are market exclusivity incentives to encourage drug manufacturers to conduct pediatric studies to develop clinical information that lead to safe and effective formulations, studies and dosing for pediatric populations. The FDA may only grant a drug pediatric exclusivity if that drug meets specific requirements. The FDA makes a written request to the manufacturer or the company can prompt the agency to make a written request for pediatric studies.
"This is an important step in working with manufacturers to bring to market drug therapies that are formulated for, studied, and dosed in actual pediatric populations," said Dianne Murphy, M.D., director of the Office of Pediatric Therapeutics for FDA. "It is our hope that other drug manufacturers will study and devise therapies specifically for children."
The approved pediatric doses were determined through clinical trials in pediatric populations. Lamisil Oral Granules are approved to be administered once a day for six weeks. The actual dosage amount will be based on the weight of the child.