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Article: Barr Receives Tentative Approval for Generic Niaspan(R) 1000 mg Extended-Release Tablets.
- Article from:
- PR Newswire
- Article date:
- May 12, 2003
CopyrightCOPYRIGHT 2003 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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Barr Laboratories, Inc. today announced that it has received tentative approval from the U.S. Food & Drug Administration (FDA) for its generic version of Kos Pharmaceutical, Inc.'s (Kos) Niaspan(R) 1000 mg Extended-Release Tablets (Niacin Extended-Release Tablet). The Company is currently challenging the validity and/or infringement of certain patents held by Kos for Niaspan 1000 mg Extended-Release Tablets and a trial in the Federal District Court in New York is currently scheduled for December 2004.
In December 2001, Barr received notice from the U.S. Food and Drug Administration (FDA) that its Abbreviated New Drug Application (ANDA) for Niacin ...
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