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Article: U.S. Food and Drug Administration Approves Supplemental New Drug Application for ANTARA(TM) 130 mg (Fenofibrate Capsules).
- Article from:
- PR Newswire
- Article date:
- November 14, 2005
CopyrightCOPYRIGHT 2005 PR Newswire Association LLC. This material is published under license from the publisher through the Gale Group, Farmington Hills, Michigan. All inquiries regarding rights should be directed to the Gale Group. (Hide copyright information)
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- Data Supports Label Change for New More Convenient Dosing Regimen -
LIBERTY CORNER, N.J., Nov. 14 /PRNewswire/ -- Reliant Pharmaceuticals, Inc. announced today that the Food and Drug Administration (FDA) has approved its Supplemental New Drug Application (SNDA) for a new dosing regimen and label change for the Company's fenofibrate therapy, ANTARA(TM) (fenofibrate capsules) 43 mg and 130 mg. The new regimen enables patients to take ANTARA(TM) 130 mg capsules with or without food, increasing convenience for the 15 percent of adults in the United States with elevated triglycerides.
The SNDA approval was based on exclusive clinical data within the ...