Galvus Approval Status
Galvus (vildagliptin) is a dipeptidyl peptidase 4 (DPP-4) inhibitor intended for use as a once-daily oral treatment for patients with type 2 diabetes.
In February 2007, Novartis Pharmaceuticals Corporation announced the receipt of an Approvable Letter from the U.S. Food and Drug Administration (FDA) requesting additional data, including a clinical study to demonstrate the safety and efficacy of Galvus (vildagliptin) in specific patient groups with renal impairment. While vildagliptin is currently available in many countries, it remains commercially undeveloped in the United States.
Development Status and FDA Approval Process for Galvus
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