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M2 EQUITYBITES-February 27, 2017-Intellipharmaceutics wins US FDA approval for 500 mg and 750 mg Generic Glucophage XR for type 2 diabetes
M2 PHARMA-February 27, 2017-Intellipharmaceutics wins US FDA approval for 500 mg and 750 mg Generic Glucophage XR for type 2 diabetes
Metformin Hydrochloride ER Tablets USP 500mg and 750mg is therapeutically equal to the reference listed drug Glucophage XR Extended-release Tablets 500mg and 750mg respectively of Bristol Myers Squibb (BMS).
Metformin also goes by the brand names Glucophage, Glumetza, Glucophage XR, and Fortamet.
Metformin is available in an oral solution (Riomet), tablet (Glucophage) and extended-release tablet (Fortamet, Glucophage XR, Glumetza).
Fatima, a diabetic patient, had voiced apprehensions about the tablet, Glucophage XR (500mg), saying it had shown up virtually unchanged in her stool.
The parties have entered into a settlement and license agreement providing for a onetime payment to Depomed of $Z5 million and a nonexclusive license to the patents in favor of Ivax and Teva to continue marketing generic Glucophage XR in the U.
Drugs with significant potential that are having generic equivalents hit the market are: Ortho-Novum 7/7/7 * (birth control) Ortho Tri-Clyclen * (birth control) Accupril (blood pressure) Nolvadex (breast cancer) Topamax (anti-convulsant) Glucophage XR (diabetes) Monopril (blood pressure) Remeron (antidepressant) Alphagan (glaucoma) Serzone (antidepressant) Glucovance (diabetes) Glucotrol XL (diabetes) Wellbutrin SR (antidepressant) Zyban (smoking cessation) Neurontin (anti-convulsant) Tiazac (blood pressure) Prozac (antidepressant) Prilosec (gastritis)
Depomed will also receive ongoing royalty payments from Teva on sales by IVAX and Teva of generic Glucophage XR.
Merck a leading science and technology company, today announced that the British Medicines and Healthcare products Regulatory Agency (MHRA), has approved on November 2 an updated labeling for Glucophage XR (extended release metformin) for the treatment of patients with type 2 diabetes.
Fatima, a diabetic patient, said she took the drug Glucophage XR (500mg) but noticed that the undissolved tablet passed out in her stool.