Pharmaceutical Business review

Barr wins FDA approval for generic Razadyne ER capsules

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.