Lupin unit gets USFDA nod for Memantine tablets

Lupin announced that its US subsidiary, Lupin Pharmaceuticals, Inc (LPI) has received the tentative approval for the company's Abbreviated New Drug Application (ANDA) for its Memantine Hydrochloride tablets, 5mg and 10mg from the US Food and Drug Administration (USFDA). Lupin's Memantine HCL tablets are AB-rated to Namenda tablets indicated for the treatment of moderate to severe dementia of the Alzheime's type Namenda had annual sales of about US$1.1bn for the twelve months ended September 2009, based on IMS health sales data. Commenting on the approval, Vinita Gupta, Group President & CEO, Lupin Pharmaceuticals Inc. said, "We are pleased to receive this tentative approval and look forward to bringing Memantine HCI tablets to the US market as an affordable generic alternative post-patent expiry".