Tuesday, June 24, 2008

FDA Approves PrandiMet, a Replaglinide and Metformin Fixed-Dose Combination Tablet for Treatment of Type 2 Diabetes

Jun 24, 2008 - Sciele Pharma, Inc. (NASDAQ:SCRX) and Novo Nordisk Inc. today announced that the U.S. Food and Drug Administration (FDA) approved PrandiMet(TM) (repaglinide and metformin HCl) tablets, the first and only fixed-dose combination of the fast-acting secretagogue replaglinide (also known as Prandin(R)) and insulin sensitizer, metformin, for the treatment of type 2 diabetes. Under a previously announced agreement, Sciele Pharma will exclusively market PrandiMet(TM) to physicians in the U.S. Sciele Pharma anticipates that PrandiMet(TM) will be available to physicians and patients in the U.S. in the second half of 2008.

PrandiMet(TM) has been approved to lower the blood glucose in adult patients with type 2 diabetes whose hyperglycemia cannot be controlled satisfactorily by meglitinide and/or metformin.

The whole story can be read here.

No comments: