The FDA Thursday evening approved Shire and Noven’s Daytrana (methylphenidate transdermal system) attention deficit hyperactivity disorder (ADHD) patch. The approval makes the patch the first such treatment available in skin patch form.
Daytrana is designed for treatment of children aged 6 to 12 with difficulty taking ADHD medications in pill form.
Analysts expect the ADHD patch to generate sales anywhere between $12 to $70 million this year.
The FDA said Daytrana would be examined along other drugs considered in March by the FDA’s pediatric drugs advisory committee.
That committee suggested that patients and doctors should be made aware of potential psychosis, aggression and cardiac effects in young people taking ADHD drugs, including Shire’s Adderall, Novartis’ Ritalin, J&J’s Concerta and Eli Lilly’s Straterra.
Among the issues it felt need to be highlighted, the panel called for warning language about cardiac risks in young people with pre-existing heart problems.
In February, an FDA advisory committee voted 8-7 to recommend a black-box warning against cardiovascular risks.
The FDA will consider both panels’ recommendations before making a final labeling decision.