Hi-Tech Pharmacal announced that the FDA has approved its Abbreviated New Drug Application (ANDA) for Lorazepam oral concentrate 2mg/mL. Lorazepam oral concentrate is the generic version of Roxane‘s Lorazepam Intensol oral concentrate.
Hi-Tech Pharmacal’s Lorazepam oral concentrate is a schedule C-IV controlled substance. It is indicated for the management of anxiety disorders or for the short-term relief of the symptoms of anxiety or anxiety associated with depressive symptoms. The product is expected to be available in May 2012.
For more information call (800) 899-3116 or visit www.hitechpharm.com.