Depomed, Inc.  has received approval from the U.S. Food and Drug Administration (FDA) for the 1000 mg strength tablets of Glumetza(TM) (metformin hydrochloride extended release tablets) for patients with type 2 diabetes.

 

Depomed, Inc.  has received approval from the U.S. Food and Drug Administration (FDA) for the 1000 mg strength tablets of Glumetza(TM) (metformin hydrochloride extended release tablets) for patients with type 2 diabetes. This approval is good news for patients with type 2 diabetes who are on metformin therapy and prefer to take fewer tablets per day.

Depomed, Inc. is a specialty pharmaceutical company,  with two approved products on the market and other product candidates in its pipeline. The company utilizes its proven, proprietary AcuForm(TM) drug delivery technology to improve existing oral medications, allowing for extended, controlled release of medications to the upper gastrointestinal tract.

Glumetza (metformin hydrochloride extended release tablets) is approved for use in adults with type 2 diabetes and is being marketed in Canada by Biovail Corporation. ProQuin(R) XR (ciprofloxacin hydrochloride) extended release tablets are approved in the United States for the once-daily treatment of uncomplicated urinary tract infections and is being marketed in the United States within the urology and Ob/Gyn specialties by Watson Pharmaceuticals. Product candidate Gabapentin GR is currently in clinical development for the treatment of two pain indications. A Phase 2 clinical trial of Gabapentin GR in menopausal hot flashes is also underway

Glumetza is contraindicated in patients with renal disease or renal dysfunction (e.g., as suggested by serum creatinine levels greater than or equal to 1.5 mg/dL in males and greater than or equal to 1.4 mg/dL in females), known hypersensitivity to metformin HCl, and acute or chronic metabolic acidosis, including diabetic ketoacidosis with or without coma.