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news.Barr Pharmaceuticals has announced that its subsidiary, Barr Laboratories, has received final approval from the FDA to manufacture and market a generic version of Ortho McNeil Janssen's Razadyne ER equivalent to 8mg, 16mg and 24mg.
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Barr has also announced that it is the first company to file an abbreviated new drug application with the FDA containing a paragraph IV certification for a generic version of Razadyne ER capsules, and therefore is entitled to 180-days of marketing exclusivity, as provided for under the Hatch Waxman Act. The company intends to launch its product shortly.