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www.fdanews.com/articles/71597-barr-receives-fda-approval-for-generic-niaspan-extended-release-tablets

Barr Receives FDA Approval for Generic Niaspan Extended-Release Tablets

April 27, 2005

Barr Pharmaceuticals has announced that its subsidiary, Barr Laboratories has received final approval from the FDA for its generic version of Kos Pharmaceutical's Niaspan 500-mg, 750-mg and 1,000-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.