From New York, New York, USA:
Have you heard anything about the new SmithKline Beecham drug, Avandia (rosiglitazone maleate)? They recently submitted it for FDA approval.
In December, 1998, SmithKline Beecham submitted a New Drug Application (NDA) for rosiglitazone maleate (Avandia) to the FDA for approval in the treatment of type 2 diabetes, either as monotherapy or in combination with other drugs. Rosiglitazone is a member of a new class of oral insulin sensitivity enhancers known as thiazolidinediones. This class also includes Rezulin (troglitazone). These medications directly target insulin resistance and thereby reduce the amount of insulin needed to obtain blood sugar control, in contrast to conventional treatments which increase insulin production in the pancreas or decrease glucose output through the liver.
At the same time SmithKline Beecham also submitted a Marketing Authorization Application (MAA) to the European Agency for the Evaluation of Medicinal Products (EMEA) to market rosiglitazone for the treatment of type 2 diabetes, either as monotherapy or in combination with other drugs.
Original posting 19 Jan 1999
Posted to Medications: Pills for Diabetes
Last Updated: Tuesday April 06, 2010 15:09:00
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