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news.Intellipharmaceutics International has submitted an abbreviated new drug application (ANDA) with the US Food and Drug Administration (FDA) for approval to market a generic of the 30mg strength of Focalin XR (dexmethylphenidate hydrochloride).
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The application for the 30mg strength is filed as an amendment to the ANDA that Intellipharmaceutics had previously filed for the 5, 10, 15 and 20mg strengths of the drug.
Earlier, in November 2009, the FDA approved the higher 30mg dose of Focalin XR extended-release capsules for the treatment of attention deficit hyperactivity disorder (ADHD).
Intellipharmaceutics claims that the new strength provides physicians with an additional treatment option that offers improvement in ADHD symptoms for up to 12 hours compared with the placebo.
Intellipharmaceutics CEO Isa Odidi said that the filing of the 30mg Focalin XRANDA is the fourth ANDA they have filed with the FDA in the last 12 months.