Intellipharmaceutics Announces FDA Approval for 500 mg and 750 mg Generic Glucophage XR

Intellipharmaceutics International, a pharmaceutical company specializing in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs announced that the Company today received final approval from the U.S. Food and Drug Administration (“FDA”) for the Company’s abbreviated new drug application (“ANDA”) for metformin hydrochloride extended release tablets in the 500 mg and 750 mg strengths.  The Company’s newly approved product is a generic equivalent for the corresponding strengths of the branded product Glucophage XR sold in the United States by Bristol-Myers Squibb.

Dr. Isa Odidi, the CEO and a co-founder of Intellipharmaceutics, stated, “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.”

Glucophage XR, and the drug active metformin, are indicated for use in the management of type 2 diabetes treatment. According to Symphony Health Solutions, sales in the United States for the 12 months ended January 2017 of the 500 mg and 750 mg strengths of Glucophage XR and all generic equivalents, were approximately $591 million (TRx MBS Dollars, which represents projected new and refilled prescriptions representing a standardized dollar metric based on manufacturer’s published catalog or list prices to wholesalers, and does not represent actual transaction prices and does not include prompt pay or other discounts, rebates or reductions in price). The Company is aware that other generic versions of this product are currently available in the market. There can be no assurance that the Company’s metformin extended-release tablets for the 500 mg and 750 mg strengths will be successfully commercialized.