Hi-Tech Pharmacal (HITK) Gets FDA Approval for Generic Lorazepam Intensol ANDA

January 31, 2012 7:05 AM EST
Hi-Tech Pharmacal Co., Inc. (Nasdaq: HITK), reports 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.


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