Impax launches additional strengths of generic Focalin XR extended-release capsules CII
Company has immediately initiated commercialization activities.
Impax Laboratories has received final FDA approval on its Abbreviated New Drug Application (ANDA) for a generic version of Focalin XR (dexmethylphenidate hydrochloride) extended-release capsules CII, 25 and 35 mg. Impax has immediately initiated commercialization activities.
This approval and launch of the 25 and 35 mg strengths complements the company's commercialized generic portfolio of Focalin XR products, which also includes strengths of 5, 10, 15, 20 and 30 mg capsules.
According to IMS Health, dexmethylphenidate hydrochloride extended-release capsules, 25 and 35 mg, had US brand and generic sales of approximately $93 million for the 12 months ending May 2017.
Dexmethylphenidate hydrochloride extended-release capsules are indicated for the treatment of Attention Deficit Hyperactivity Disorder (ADHD) in patients aged 6 years and older.
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