Obesity & Diabetes Week
Welcome to NewsRx!
Learn more about a six-week, no-risk free trial of Obesity & Diabetes Week
We're a pay-per-view site for premium content. If you'd like to purchase this article, it's only $3.00.
Diabetes Therapy
Novartis announces extension of regulatory review for Galvus
December 11th, 2006
Novartis announced an extension in the U.S. regulatory review period for the oral anti-diabetes medicine Galvus (vildagliptin) until the end of February 2007 after deciding to submit recently available clinical data to the U.S. Food and Drug Administration (FDA). These additional data being submitted to the FDA add about 1,000 patient years of treatment experience with Galvus. These recently available data include results from short- and long-term studies for periods of up to two years, both as a monotherapy or in combination with other anti-diabetes medicines. These new data further support the proposed dosing regimen and indications as well as...
Source: Obesity & Diabetes Week (2006-12-11)
|
