Jan. 20, 2010Products
Oral hypoglycemic drug METGLUCO obtained a manufacturing and marketing approval
Dainippon Sumitomo Pharma Co., Ltd. (DSP, Headquarters: Osaka, Japan; President: Masayo Tada) announced that it has obtained a manufacturing and marketing approval for "METGLUCO® tablet 250mg" (generic name: metformin hydrochloride), an oral hypoglycemic drug, in Japan as of January 20, 2010 from the Ministry of Health, Labor and Welfare.
METGLUCO® is a biguanide oral hypoglycemic drug, showing blood-glucose lowering effect by way of inhibitory action against hepatic glyconeogenesis, stimulatory action for glucose uptake in the peripheral tissue and inhibitory action against intestinal glucose absorption, without the stimulation of insulin secretion.
In 1961, DSP developed and launched "MELBIN® tablet" containing metformin hydrochloride for the first time in Japan.
Metformin drugs have been widely used as the first choice for treatment of type 2 diabetes in Europe and the U.S. In order to have metformin employed for the appropriate indication and dose, and to have it supplied for medical practice as soon as possible, in 2003 DSP licensed-in Glucophage® (namely METGLUCO® in Japan) which has already been approved for manufacturing and marketing in more than 100 countries, complete with an abundance of clinical and non-clinical evidence, from Merck Sante s.a.s. (France). DSP conducted clinical trials using this drug in Japan and applied for manufacturing approval of this drug as Japanese brand name METGLUCO® tablet 250mg.
METGLUCO® can be prescribed as a monotherapy, dosed at 750-1500mg as the daily maintenance dosage or 2250mg as the highest daily dosage. Thus METGLUCO® represents a breakthrough in the diabetes therapy as the existing metformin drugs only allow daily dosages of maximum 750mg. METGLUCO® may be taken not only after meals, but just before meals as well.
DSP plans to sell METGLUCO® after it is listed in the national health insurance drug price listing, and expects that the launch of METGLUCO® will provide a new choice of treatment for type 2 diabetic patients and contribute to furthering the therapy for type 2 diabetes.
Merck Sante s.a.s. is part of Merck Serono Division. Merck Serono is a Divison for innovative prescription pharmaceuticals of Merck KGaA, Darmstadt, Germany.
|[Brand Name]||METOGLUCO® tablet 250mg|
|[Generic Name]||Metformin hydrochloride|
|[Content / Description]||One tablet contains 250mg of metformin hydrochloride|
|[Indication]||Type 2 diabetes
To be administered only when adequate effectiveness of either of the following treatments is not obtained:
(1) solely diet therapy / exercise therapy
(2) use of sulfonylurea drugs in addition to diet therapy / exercise therapy
|[Dose and Administration]||Start with the usual adult dosage of 500mg of metformin hydrochloride per day,; determine the usual maintenance dosage of 750mg - 1500mg per day while observing its effect; keep the highest dosage at 2250mg maximum per day while there may be a rise or fall in dosage depending on patient's symptoms.
The daily dose is divided into two to three portions for oral administration either just before or after a meal
|[Manufacturer and Distributor]||Dainippon Sumitomo Pharma Co., Ltd.|