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7 Jan 2013

ADHD extended-release tablets approved by FDA

FDA approval has been granted to new generic ADHD extended-release tablets from Mallinckrodt.

Pharmaceuticals business Mallinckrodt has received approval from the US Food and Drug Administration for the manufacturing and marketing of a generic version of Concerta tablets for the treatment of Attention Deficit Hyperactivity Disorder (ADHD).

The methylphenidate HCI extended-release tablets will be produced in 27, 36 and 54mg dosage strengths, with the 27mg tablets to be launched immediately.

Such tablets are used for the treatment of ADHD in children aged six years and above, as well as adolescents and adults with the condition up to the age of 65.

Mallinckrodt said that it holds separate 180-day exclusivity periods for each of the dosage strengths starting from their respective commercial launches. With that in mind, it intends to have the 36mg and 54mg tablets available commercially by the end of the first calendar quarter of 2013.

It is also currently applying for approval of an 18mg dosage strength methylphenidate HCI extended-release tablet.

Mark Trudeau, president of the company, said: "This approval represents an important addition to our line of generic pharmaceutical products and we look forward to providing an affordable treatment option to patients coping with ADHD.

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