IntelliPharmaCeutics Intl Inc (USA) (NASDAQ:IPCI) received final approval from the FDA for the Company’s abbreviated new drug application 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.

Shares of Intellipharmaceutics are rising about 28% to $2.75 in pre-market trading Friday. IPCI has a 1-year high of $3.35 and a 1-year low of $1.41. The stock’s 50-day moving average is $2.65 and its 200-day moving average is $2.50.

On the ratings front, IPCI has been the subject of a number of recent research reports. In a report issued on February 13, Aegis analyst Difei Yang reiterated a Buy rating on IPCI, with a price target of $8.00, which represents a potential upside of 272% from where the stock is currently trading. On February 3, Maxim’s Jason Kolbert reiterated a Buy rating on the stock and has a price target of $6.00.

According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Difei Yang and Jason Kolbert have a yearly average return of 3.7% and a loss of -13.2% respectively. Yang has a success rate of 42% and is ranked #1249 out of 4499 analysts, while Kolbert has a success rate of 32% and is ranked #4431.

Intellipharmaceutics International, Inc. is a pharmaceutical company, which engages in the research, development and manufacture of novel and generic controlled-release and targeted-release oral solid dosage drugs. Its patented Hypermatrix technology is a multidimensional controlled-release drug delivery platform that can be applied to the development of existing and new pharmaceuticals in the areas of neurology, cardiovascular, gastrointestinal tract, diabetes and pain.