FDA OKs generic Ritalin for Actavis and Mylan's Keppra

Iceland-based generic drugmaker Actavis says that it recently received approval from the US Food and Drug Administration to market methylphenidate hydrochloride extended-release capsules (LA) CII, USP, 20mg, 30mg, and 40mg. Actavis has first-to-file exclusivity on these dosage forms and says distribution of the product has commenced.

The product is the generic equivalent of Swiss drug major Novartis’ (NOVN: VX) longer-acting attention-deficit hyperactivity disorder (ADHD) drug Ritalin LA, which had US sales of around $80.7 million for the 12 months ending September 30, 2011, according to IMS Health. The Novartis drug was approved by the FDA in June 2002.

Commenting on the new approval, Doug Boothe, chief executive of Actavis in the USA, said: "The approval and launch of methylphenidate hydrochloride extended-release capsules (LA) offers a significant value to our customers and patients. This approval, along with the first-to-file exclusivity, also underscores Actavis' emphasis and commitment to bringing complex controlled-release products to the marketplace."