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news.Hi-Tech Pharmacal has received FDA approval for its abbreviated new drug application, (ANDA) for Lorazepam oral concentrate 2mg/mL.
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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.
The company is planning to launch the product by May 2012.
Lorazepam oral concentrate 2mg/mL is the generic for Roxanne’s Lorazepam Intensol oral concentrate.
Roxanne’s Lorazepam Intensol oral concentrate has combined brand and generic sales of $10m for the 12 months ended December 2011, according to IMS sales data.