US FDA grants tentative approval for LPI's Memantine HCl tablets

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Jan 21 2010

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Lupin Pharmaceuticals, Inc. (LPI) announced today that it has received tentative approval from the US Food and Drug Administration (US FDA) for its Memantine Hydrochloride tablets, 5mg and 10mg.

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.

Commenting on the approval, Vinita Gupta, President and CEO of Lupin Pharmaceuticals, Inc., said, "We are pleased to receive this tentative approval and look forward to bringing Memantine HCl tablets to the US market as an affordable generic alternative post patent expiry."

SOURCE Lupin Pharmaceuticals, Inc.

Posted in: Medical Condition News | Pharmaceutical News

Tags: Alzheimer's Disease, Asthma, Dementia, Drug Delivery, Food, Pediatrics, Pharmaceuticals

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