FDA approves Actavis ADHD drug
MORRISTOWN, N.J. — The Food and Drug Administration has approved a generic version of a drug for attention deficit hyperactivity disorder made by Actavis, the drug maker said Wednesday.
Actavis announced the FDA approval of methylphenidate hydrochloride extended-release capsules in the 20-mg, 30-mg and 40-mg strengths, a generic version of Novartis's Ritalin LA. Actavis said it was the first to file for regulatory approval of the drug in those three strengths, thus entitling it to 180 days of market exclusivity in which it will directly compete with the branded version.
The drug had sales of $80.7 million during the 12-month period ended in September, according to IMS Health.