The FDA has approved Kremers Urban Pharmaceuticals‘ (a subsidiary of UCB) Methylphenidate HCl Extended-Release Tablets, the generic version of Janssen’s Concerta.

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Methylphenidate is a CNS stimulant indicated for the treatment of attention deficit hyperactivity disorder (ADHD). Methylphenidate is thought to block the reuptake of norepinephrine and dopamine into the presynaptic neuron and increase the release of these monoamines into the extraneuronal space.

Methylphenidate HCl Extended-Release Tablets are currently available in 18mg and 27mg dosage strengths. The company has also received tentative approval for the 36mg and 54mg dosage strengths, and will be eligible for final approval in September 2013.

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