Hi-Tech Pharmacal (HITK) Receives Final Approval for Lorazepam Oral Concentrate
1/31/2012 6:38:25 AM
AMITYVILLE, N.Y.--(BUSINESS WIRE)--Hi-Tech Pharmacal Co., Inc. (NASDAQ: HITK), a specialty pharmaceuticals company, announced today that the US Food and Drug Administration, (FDA) granted final approval for the Company's Abbreviated New Drug Application, (ANDA) for Lorazepam oral concentrate 2mg/mL, the generic for Roxanne’s Lorazepam Intensol® oral concentrate which had combined brand and generic sales of $10 million for the 12 months ended December 2011 according to IMS sales data. The product 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. Hi-Tech plans to launch the product by May 2012.