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FDA approves paediatric Lamisil for scalp ringworm

The FDA approves Novartis' Lamisil Oral Granules for the treatment of tinea capitis, a fungal infection of the scalp, in children aged over four years in the US

The FDA has approved Novartis' Lamisil Oral Granules for the treatment of tinea capitis, a fungal infection of the scalp, in children aged over four years in the US.

The FDA, in a paediatric written request, approached Novartis for a Lamasil (terbinafine) formulation palatable for children. As a result, the new dosage form is granules, which can be sprinkled on food.

Under the Best Pharmaceuticals Children's Act of 2002, there are market exclusivity incentives in the US to encourage manufacturers to conduct paediatric studies to develop clinical information that lead to safe and effective formulations, studies and dosing for paediatric populations.

The FDA only grants paediatric exclusivity for a drug, if it 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 paediatric studies.

The approved paediatric doses were determined through clinical trials in paediatric 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.

Dr Dianne Murphy, director of the office of paediatric therapeutics for the 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 paediatric populations. It is our hope that other drug manufacturers will study and devise therapies specifically for children."

EU still slow to approve paediatric products
Far fewer paediatric products are approved in the EU, compared with the US. The European Medicines Agency's (EMEA) Paediatric Committee (PDCO) has recently made first requests for paediatric investigation plans (PIPs) and waivers and continues to refine the procedural aspects for the operation of paediatric activities, but progress is slow.

PDCO also agreed on a proposal on the format and content of the information to be collected by Member States regarding all existing uses of medicinal products in the paediatric population by January 2009.

The draft implementing strategy will be sent to the EU Commission and presented to the EMEA Management Board sometime in October 2007. Final adoption is anticipated for January 2008.

30th September 2008

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