Intellipharmaceutics wins US FDA approval for 500 mg and 750 mg Generic Glucophage XR for type 2 diabetes.
M2 EQUITYBITES-February 27, 2017-Intellipharmaceutics wins US FDA approval for 500 mg and 750 mg Generic Glucophage XR for type 2 diabetes
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Pharmaceutical company Intellipharmaceutics International Inc (TSX:I) reported on Friday the receipt of final approval from the US Food and Drug Administration (FDA) for its abbreviated new drug application (ANDA) for metformin hydrochloride extended release tablets in the 500 mg and 750 mg strengths.
The company's abbreviated new drug application (ANDA) for metformin hydrochloride extended release tablets in the 500 mg and 750 mg strengths is the generic equivalent for the corresponding strengths of the branded product Glucophage XR sold in the US by Bristol-Myers Squibb.
According to the company, Glucophage XR and the drug active metformin are indicated for use in the management of type 2 diabetes treatment.
For the 12 months ended January 2017, the sales of the 500 mg and 750 mg strengths of Glucophage XR and all generic equivalents, were approximately USD591m in the US, according to Symphony Health Solutions.
Intellipharmaceutics added that there can be no assurance that the company's metformin extended-release tablets for the 500 mg and 750 mg strengths will be successfully commercialised.
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|Publication:||M2 EquityBites (EQB)|
|Date:||Feb 27, 2017|
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