Lupin gets USFDA approval for generic Lexapro tablets
New Delhi: Drug firm Lupin Ltd Thursday said it has received American health regulator's approval to market Escitalopram tablets, used in treating depressive disorders, in the US market.
The company's subsidiary Lupin Pharmaceuticals Inc has received final approval from US Food and Drug Administration (USFDA) for its Escitalopram tablets in strengths of 5 mg, 10 mg, and 20 mg, Lupin said in a statement.
Lupin's product is the generic version of Forest Laboratories Inc's Lexapro tablets and is indicated for treatment of major depressive disorder in adults and adolescents aged 12-17 years as also for the acute treatment of general anxiety disorder in adults, it added.
According to IMS Health sales data, Lexapro tablets had annual US sales of around USD 2.7 billion for the 12-month period ending March, 2012.
The Mumbai-headquartered firm has so far filed 176 product applications with the USFDA and has received 65 approvals till date.
Shares of Lupin Thursday closed at Rs 599.20 on the BSE, down 3.19 percent from their previous close.