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Article: FDA Issues Approvable Letter for Expanded Use of Vivelle-Dot and Addition of New Low Dose Strength.
- Article from:
- Business Wire
- Article date:
- December 11, 2001
CopyrightCOPYRIGHT 2001 Business Wire. 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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Business Editors/Health & Medical Writers
MIAMI--(BUSINESS WIRE)--Dec. 11, 2001
Novogyne's Dime-Sized Patch Will Be Smallest Estrogen Patch
Ever Marketed
Noven Pharmaceuticals, Inc. (Nasdaq:NOVN), a leader in the development of transdermal and transmucosal drug delivery systems, announced today that the U.S. Food and Drug Administration (FDA) has issued to Novartis Pharmaceuticals Corporation an approvable letter relating to the expanded use of Vivelle-Dot(TM) (estradiol transdermal system) and the addition of a new low dose strength.
Currently, Vivelle-Dot is approved for the treatment of menopausal symptoms. The expanded use ...