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news.Mallinckrodt has won FDA approval to manufacture and market generic Concerta (methylphenidate HCl) extended-release (ER) tablets USP (CII) in 27mg, 36mg and 54mg dosage strengths in the US.
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The company will immediately introduce 27mg dose of Methylphenidate HCl ER tablets and anticipates introducing 36mg and 54mg doses in the first quarter of 2013.
Methylphenidate HCl ER Tablets are indicated to treat attention deficit hyperactivity disorder (ADHD) in children six years of age to adults up to 65 years.
Mallinckrodt president Mark Trudeau said, "We are pleased the FDA found that our long-acting technology delivers a dose which is therapeutically equivalent to what is currently on the market."
The company believes to hold separate market exclusivity period of 180 days for each of the three dosage strengths 27mg, 36mg and 54mg, which begins upon launch of each respective dosage strength.