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Galvus FDA Approval Status

FDA Approved: No
Brand name: Galvus
Generic name: vildagliptin
Previous Name: LAF237
Company: Novartis Pharmaceuticals Corporation
Treatment for: Diabetes, Type 2

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 timeline for Galvus

Feb 26, 2007Novartis Committed to Making Galvus Available for Patients with Type 2 Diabetes After US Regulators Issue ''Approvable Letter''
Nov 13, 2006Novartis announces three-month extension of US regulatory review for Galvus to assess recently available clinical data
Mar 30, 2006New drug application for Galvus, an innovative oral therapy for people with type 2 diabetes, accepted for review by FDA

Further information

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