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Article: Barr Receives Final FDA Approval for Generic Niaspan(R) Extended-Release Tablets.
- Article from:
- PR Newswire
- Article date:
- April 27, 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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WOODCLIFF LAKE, N.J., April 27 /PRNewswire-FirstCall/ -- Barr Pharmaceuticals, Inc. today announced that its subsidiary, Barr Laboratories, Inc., has received final approval from the U.S. Food & Drug Administration (FDA) for its generic version of Kos Pharmaceutical, Inc.'s (Kos) Niaspan(R) 500 mg, 750 mg and 1000 mg Extended-Release Tablets (Niacin Extended-Release Tablets). The final approval follows the expiration of Kos' 30-month stay under the Hatch-Waxman patent challenge provisions and the resolution of the litigation between Barr and Kos regarding the Niaspan products.
On April 13, 2005 Barr and Kos announced that they had entered in to Settlement and ...