Intellipharmaceutics Files ANDA With FDA For 30 Mg Focalin XR(R)
TORONTO, Dec. 7, 2010 (GLOBE NEWSWIRE) -- Intellipharmaceutics International Inc. (Nasdaq:IPCI) (TSX:I), today announced that it has filed an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for approval to market a generic of the 30 mg strength of Focalin XR® (dexmethylphenidate hydrochloride). The application for the 30 mg strength is filed as an amendment to the ANDA that Intellipharmaceutics had previously filed for the 5, 10, 15 and 20 mg strengths of the drug.
"The filing of the 30 mg Focalin XR®ANDA is the fourth ANDA we have filed with the FDA in the last 12 months," commented Dr. Isa Odidi, CEO of Intellipharmaceutics. "This filing demonstrates our ability to quickly and efficiently develop controlled release products in-house for filing with the FDA."
In November 2009, the FDA approved the higher 30 mg dose of Focalin XR® extended-release capsules for the treatment of Attention Deficit Hyperactivity Disorder (ADHD). The new strength provides physicians with an additional treatment option that offers statistically significant improvement in ADHD symptoms for up to 12 hours compared with the placebo. According to IMS Health, Focalin XR® had U.S. sales of about US$355 million in 2009; the Company projects sales growth for 2010 to approximately US$420 million.Intellipharmaceutics' application for approval of generic versions of Focalin XR® remains subject to FDA approval. No assurance can be given as to whether or when the FDA will approve the Company's generic versions of Focalin XR®. About Intellipharmaceutics Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel or generic controlled release and targeted release oral solid dosage drugs. The Company's patented Hypermatrix™ technology is a multidimensional controlled-release drug delivery platform that the Company believes can be applied to the efficient development of a wide range of existing and new pharmaceuticals. Based on this technology, Intellipharmaceutics has a pipeline of products in various stages of approval and development in therapeutic areas that include neurology, cardiovascular, GIT, pain and infection.
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