Andrew
12-23-05, 11:23 PM
The FDA told the manufacturer of the first skin patch to treat attention deficit hyperactivity disorder in children that the agency would approve the product if certain conditions are met, the company said Friday.
In a letter to Noven Pharmaceuticals Inc., the Food and Drug Administration included proposed changes to how the patch is labeled, the Miami-based company said. The FDA also asked that the company clarify some data and conduct surveillance and study of the product once it is on the market. The patch would be sold under the name Daytrana.
Earlier this month, an FDA panel of independent experts voted to recommend that the patch's label encourage its use as an alternative treatment for children between the ages of 6 and 12 with ADHD, meaning doctors should prescribe it only if taking pills is too difficult for a child.
The patch is designed to go on a child's hip for nine hours, according to U.K.-based Shire Pharmaceuticals Group PLC and Noven Pharmaceuticals, which codeveloped the product.
It releases into the body methylphenidate, shown to help children with ADHD. It is the same stimulant that is in Ritalin.
The patch can be removed if it causes side effects.
Noven in 2003 submitted a 12-hour version of the patch to the FDA. The agency rejected it and recommended Noven test a nine-hour version.
Source: http://news.yahoo.com/s/ap/20051224/ap_on_he_me/attention_deficit_patch&printer=1;_ylt=Aue3aVrXZjThGR4.tVVPWGFa24cA;_ylu=X 3oDMTA3MXN1bHE0BHNlYwN0bWE-
In a letter to Noven Pharmaceuticals Inc., the Food and Drug Administration included proposed changes to how the patch is labeled, the Miami-based company said. The FDA also asked that the company clarify some data and conduct surveillance and study of the product once it is on the market. The patch would be sold under the name Daytrana.
Earlier this month, an FDA panel of independent experts voted to recommend that the patch's label encourage its use as an alternative treatment for children between the ages of 6 and 12 with ADHD, meaning doctors should prescribe it only if taking pills is too difficult for a child.
The patch is designed to go on a child's hip for nine hours, according to U.K.-based Shire Pharmaceuticals Group PLC and Noven Pharmaceuticals, which codeveloped the product.
It releases into the body methylphenidate, shown to help children with ADHD. It is the same stimulant that is in Ritalin.
The patch can be removed if it causes side effects.
Noven in 2003 submitted a 12-hour version of the patch to the FDA. The agency rejected it and recommended Noven test a nine-hour version.
Source: http://news.yahoo.com/s/ap/20051224/ap_on_he_me/attention_deficit_patch&printer=1;_ylt=Aue3aVrXZjThGR4.tVVPWGFa24cA;_ylu=X 3oDMTA3MXN1bHE0BHNlYwN0bWE-