![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Barr Receives FDA Approval for Generic Niaspan Extended-Release Tablets
Barr Receives FDA Approval for Generic Niaspan Extended-Release Tablets
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.
KEYWORDS Drug Pipeline Alert
Upcoming Events
-
21Oct