Pharma major, Lupin’s subsidiary - Lupin Pharmaceuticals Inc (collectively Lupin) has received final approval for its Lorazepam Oral Concentrate USP, 2 mg/mL from the United States Food and Drugs Administration (US FDA) to market a generic version of Lorazepam Intensol, 2 mg/mL, of Roxane Inc.
Lupin’s Lorazepam Oral Concentrate USP, 2 mg/mL 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. Lorazepam Oral Concentrate had annual US sales of approximately $10.7 million (IMS MAT Sept 2012 sales).
Lupin is the 5th largest and fastest growing generics player in the US (5.1% market share by prescriptions, IMS Health) and the 3rd largest Indian pharmaceutical company by sales. The company is also the fastest growing top 10 generic pharmaceutical players in Japan and South Africa (IMS).