FDA Approves Lamisil For Scalp Ringworm Treatment For Children

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Main Category: Dermatology
Also Included In: Pediatrics / Children's Health;  Infectious Diseases / Bacteria / Viruses;  Regulatory Affairs / Drug Approvals
Article Date: 29 Sep 2007 - 0:00 PDT

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The Food and Drug Administration (USA) has approved Lamisil for the treatment of tinea capitis (scalp ringworm) for children aged 4 or more. The medication is presented in oral granules. Children are most susceptible to tinea capitis - an infected patient can experience severe itching, dandruff and bald patches. The fungal infection does not usually respond to topical treatment - it is persistent and contagious.

Steven Galson, M.D., M.P.H., Director, Center for Drug Evaluation and Research (FDA), said "Tinea capitis is a persistent infection that is hard to treat, and one that causes children embarrassment. 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 had approached the manufacturers of Lamisil, Novartis Pharmaceuticals Corporation, for a presentation of the drug that might be more pleasant for children tot ake. The company came up with granules, which can be sprinkled on food.

According to the Best Pharmaceuticals Children's Act of 2002, there are market exclusivity incentives to get pharmaceutical companies interested in conducting pediatric studies to develop clinical information that lead to safe and effective formulations, studies and dosing for pediatric populations. The FDA will only grant a drug pediatric exclusivity if that drug meets detailed requirements. The FDA makes a request, in writing to the manufacturer. The manufacturer can encourage the FDA to make a written request for pediatric studies.

Dianne Murphy, M.D., Director, Office of Pediatric Therapeutics, FDA. said "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. It is our hope that other drug manufacturers will study and devise therapies specifically for children."

The Lamisil Oral Granules have been approved to be given once a day for a period of six weeks. Dosage depends on how much the child weighs.

http://www.novartis.com

Written by: Christian Nordqvist


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