TORONTO, ON-The FDA has given Toronto-based Intellipharmaceutics International approval for its generic version of Bristol-Myers Squibb’s Glucophage XR, or metformin hydrochloride, for patients with type 2 diabetes.
The drug, metformin hydrochloride extended release tablets, will be sold in 500- and 750-mg strengths.
“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,” Dr. Isa Odidi, the CEO and a co-founder of Intellipharmaceutics, stated.
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 U.S. 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.