Intellipharmaceutics International (NASDAQ: IPCI) shares were up 27% this morning following news that it has received final approval for its abbreviated new drug application (ANDA) for metformin hydrochloride extended release tablets in the 500 mg and 750 mg strengths from the U.S. Food and Drug Administration (FDA). Metformin hydrochloride extended release is a generic equivalent for the matching strengths of the branded product Glucophage® XR, which is sold in the United States by Bristol-Myers Squibb and indicated for use in the management of type 2 diabetes. “FDA approval of our application for a generic version of Glucophage® XR provides further indication that the FDA is making progress to clear its backlog of ANDA drug candidates under review, and further validation of our core drug development and regulatory capability. We are encouraged that some of the Company’s other 8 ANDA candidates may be accorded further attention soon. We are actively evaluating options to realize commercial returns from this new approval,” Intellipharmaceutics co-founder and CEO Dr. Isa Odidi stated in the news release.
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Intellipharmaceutics International Inc. is a pharmaceutical company specializing in the research, development and manufacture of novel and 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 can be applied to the efficient development of a wide range of existing and new pharmaceuticals. Based on this technology platform, Intellipharmaceutics has developed several drug delivery systems and a pipeline of products and product candidates in various stages of development, including ANDAs filed with the FDA in therapeutic areas that include neurology, cardiovascular, gastrointestinal tract, diabetes and pain. Intellipharmaceutics also has New Drug Application 505(b)(2) specialty drug product candidates in its development pipeline. These include Rexista™ based on its proprietary nPODDDS™ novel Point Of Divergence Drug Delivery System. The company’s current development effort is increasingly directed towards improved difficult-to-develop controlled-release drugs which follow an NDA 505(b)(2) regulatory pathway. The company has increased its research and development emphasis towards new product development, facilitated by the 505(b)(2) regulatory pathway, by advancing the product development program for both Rexista™ and Regabatin™. For more information, visit www.intellipharmaceutics.com.
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