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Monday, March 8, 2010

Lupin : US FDA tentative approval for Memantine HCl tablets

LupinJanuary 20, 2010 - Pharma major, Lupin Ltd announced that its U.S 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 (US FDA).

Lupin’s Memantine HCl tablets are AB-rated to Namenda® tablets indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Namenda had annual sales of approximately $1.1 billion for the twelve months ended September 2009, based on IMS Health sales data... Lupin's Press Release -