Glucophage Approval

- Lipha's Glucophage (metformin hydrochloride) was approved on December 29 in the USA for monotherapy of non-insulin-dependent diabetes mellitus. It may also be used in combination with sulfonylurea drugs. The agent will be marketed by Bristol-Myers Squibb in 500mg and 850mg tablet formulations. Prospects for metformin are promising, as it becomes one of the few agents to challenge the commanding position held by Upjohn's Micronase and Glynase PresTabs (glyburide) in the oral diabetes drug market. Lipha has committed to carrying out a 10,000-patient, Phase IV trial to assess the incidence of lactic acidosis with the drug.