FDA approves generic Lorazepam Intensol

HAUPPAUGE, N.Y. The Food and Drug Administration has approved a generic drug for anxiety disorder made by Amneal Pharmaceuticals, Amneal said Wednesday.

The FDA approved lorazepam oral concentrate, a generic version of Roxane Labs’ Lorazepam Intensol, in the 2-mg-per-mL strength. The drug is a schedule IV controlled substance. Amneal said it received approval to manufacture the drug in December 2009 and began shipping it in March. The drug is sold as a clear, flavorless liquid that can be mixed with other liquids or semisolid food.

“Launching lorazepam oral concentrate adds yet another capability to Amneal’s distribution organization – refrigerated shipping,” Amneal EVP sales and marketing Jim Luce said. “This also offers a nice expansion to our aggressively growing liquid products portfolio, all generated from our Branchburg, N.J., liquids plant.”