 |
 |
 |
|
 |
FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA
Consumer Update |
FDA has approved Lamisil Oral Granules to treat tinea capitis, a fungal infection of the scalp, in children ages 4 years and older. The condition, also called scalp ringworm, is often characterized by severe itching, dandruff, and bald patches. It is a persistent and contagious infection that usually does not respond to topical treatment.
In a pediatric written request, FDA approached Novartis Pharmaceuticals Corporation of East Hanover, N.J., the manufacturer of Lamisil (terbinafine hydrochloride), for a formulation palatable for children. The company formulated granules, a new dosage form that can be sprinkled on food.
"Tinea capitis is a persistent infection that is hard to treat, and one that causes children embarrassment," says 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 approved pediatric doses were determined through clinical trials in children. Lamisil Oral Granules are approved to be administered once a day for six weeks. The actual dosage amount will be based on the child's weight.
Under the Best Pharmaceuticals Children's Act of 2002, there are market exclusivity incentives to encourage drug manufacturers to conduct pediatric studies. This helps to develop clinical information that leads to safe and effective formulations and dosing for children.
FDA may only grant pediatric exclusivity if the drug meets specific requirements. The agency 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," says 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."
Date Posted: October 9, 2007
