FDA Approves Actavis’s Generic Ritalin LA

Actavis Inc. Jan. 4 announced that the Food and Drug Administration has approved its generic version of Novartis AG’s Ritalin LA (methylphenidate hydrochloride extended-release capsules) in the 20 mg, 30 mg, and 40 mg strengths.

Ritalin LA is used to treat attention deficit-hyperactivity disorder (ADHD). Actavis said it was the first company to file an abbreviated new drug application for Ritalin LA in these strengths and has 180 days of exclusivity for the product.

Distribution of the product has commenced, the Morristown, N.J.-based company said.