This article is more than 5 years old. Information may no longer be current.

FDA approves additional strengths of generic Focalin XR

Impax Laboratories recently announced the FDA approval and launch of its generic version of Focalin XR extended-release capsules CII at 25-mg and 35-mg strengths.

The launch of the new strengths will complement the currently available 5-mg, 10-mg, 15-mg, 20-mg and 30-mg capsules of Focalin XR (dexmethylphenidate hydrochloride, Novartis). Dexmethylphenidate hydrochloride extended-release capsules are currently approved for the treatment of ADHD in patients aged 6 years and older, according to an Impax Laboratories press release.

Dexmethylphenidate hydrochloride 25- to 35-mg extended-release capsules have had U.S. brand and generic sales of approximately $93 million for a 12-month period ending May 2017, according to IMS Health.

Impax Laboratories has announced it will immediately begin commercialization activities for the new dexmethylphenidate hydrochloride strengths.