01:02:57 EDT Thu 25 Apr 2024
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IntelliPharmaCeutics International Inc
Symbol I
Shares Issued 29,973,400
Close 2017-02-23 C$ 2.81
Market Cap C$ 84,225,254
Recent Sedar Documents

IntelliPharma receives final OK for generic Glucophage

2017-02-24 09:31 ET - News Release

Dr. Isa Odidi reports

INTELLIPHARMACEUTICS ANNOUNCES FDA APPROVAL FOR 500 MG AND 750 MG GENERIC GLUCOPHAGE XR

IntelliPharmaCeutics International Inc. 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-milligram and 750-milligram 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 chief executive officer 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 eight 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-milligram and 750-milligram 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-milligram and 750-milligram strengths will be successfully commercialized.

About IntelliPharmaCeutics International Inc.

IntelliPharmaCeutics International 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.

Intellipharmaceutics also has new drug application 505(b)(2) specialty drug product candidates in its development pipeline. These include Rexista abuse-deterrent oxycodone hydrochloride extended-release tablets), based on its proprietary novel point-of-divergence drug delivery system (for which an NDA has been filed with the FDA), and Regabatin XR (pregabalin extended-release capsules).

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