FDA approves Teva ADHD drug
JERUSALEM — The Food and Drug Administration has approved a generic drug for attention deficit hyperactivity disorder made by Teva Pharmaceutical Industries, the Israeli generic drug maker said.
Teva announced the approval of dextroamphetamine and amphetamine extended-release capsules, a generic version of Shire's Adderall XR, in the 5 mg, 10 mg, 15 mg, 20 mg, 25 mg and 30 mg strengths. Teva sells a generic version of Adderall XR under a 2006 license and distribution agreement with Shire as part of a settlement of a patent lawsuit that Shire filed against Teva subsidiary Barr Pharmaceuticals. Teva has the right to be supplied the product by Shire until April 2014.
Generic and branded versions of the drug had sales of about $2 billion in 2012, according to IMS Health.