BALTIMORE, Sept. 14, 2011 /PRNewswire/ — Lupin Pharmaceuticals,
Inc. (LPI) announced today that the U.S. Food and Drug
Administration (FDA) has granted final approval for the Company’s
Abbreviated New Drug Application (ANDA) to market a generic version
of UCB’s KEPPRA XR tablets. Commercial shipment of the
product has commenced.
Lupin’s levetiracetam 500 mg and 750 mg extended-release tablets
are the AB-rated generic equivalent of KEPPRA XR, an antiepileptic
drug indicated for adjunctive therapy in the treatment of partial
onset seizures in patients >/= 16 years of age with epilepsy.
KEPPRA XR tablets had annual sales of approximately $161
million for the twelve months ended June 2011 based on IMS Health
sales data.
About Lupin
Headquartered in Mumbai, India, Lupin Limited is an innovation
led transnational pharmaceutical company producing a wide range of
quality, affordable generic and branded formulations and APIs.
The Company today has significant market share in
Cardiovasculars, Diabetology, Asthma, Pediatrics, CNS, GI,
Anti-Infectives and NSAIDs in addition holding global leadership
positions in the Anti-TB and Cephalosporins space.
Today, Lupin is the 5th largest and fastest growing generics
player in the US (by prescriptions), the only Asian company to
achieve that distinction. The company is also the fastest
growing top 10 pharmaceutical player in India, Japan and South
Africa. (IMS Health)
For the financial year ended March 2011, Lupin’s Consolidated
Revenues and Profit after Tax were Rs. 57,068 million (USD 1.28
Billion) and Rs. 8,626 million (USD 193 million) respectively.
Please visit http://www.lupinworld.com for
more information about Lupin Ltd.
Lupin Pharmaceuticals, Inc. is the U.S. wholly owned subsidiary
of Lupin Limited. Headquartered in Baltimore, Maryland, Lupin
Pharmaceuticals, Inc. is dedicated to delivering high
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