New Delhi, Jun 16 (UNI) Lupin Ltd today said its subsidiary Lupin Pharmaceuticals Inc (LPI) in the US has received tentative approval for the Abbreviated New Drug Approval (ANDA) for Escitalopram Oxalate Tablets 10 mg and 20 mg from the US Food and Drug Administration (USFDA).
Lupin' Escitalopram tablets are the AB-rated generic equivalent of Lexapro tablets, indicated for the treatment of major depressive disorder, a company statement said.
The product will be introduced in the market through LPI's network of national wholesalers and drug stores post patent expiry in March 2012. This will strengthen the company's presence in the Selective Serotonin Reuptake Inhibiotor segment.
With the approval of Escitalopram Oxalate Tablets, the cumulative ANDA approvals stands at 30, including three tentative approvals, with 33 pending approvals from the USFDA.
UNI SR PDT BD1422