Navigation Links
Lupin Receives USFDA Approval for Topiramate Tablets
Date:5/30/2008

BALTIMORE, May 30 /PRNewswire/ -- Lupin Pharmaceuticals, Inc. (LPI) announced today that it has received tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Topiramate tablets, 25 mg, 50 mg, 100 mg and 200 mg from the U.S. Food and Drug Administration (USFDA).

Lupin's Topiramate tablets are the AB-rated generic equivalent of Ortho-McNeil's TOPAMAX(R) tablets, indicated for the treatment of seizures. The brand product had annual sales of approximately $2.2 billion for the twelve months ended March 2008, based on IMS Health sales data.

Commenting on the approval, Vinita Gupta, President and Managing Director of Lupin Pharmaceuticals, Inc. said, "Lupin is pleased to receive this approval that will enable the Company to offer Topiramate tablets as an affordable generic alternative that will have a measurable impact on the U.S. healthcare system."

The product will be introduced in the market through LPI's strong network of national wholesalers and drug stores post patent expiry in September 2008. This will strengthen Lupin's presence in the CNS segment.

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 for the developed and developing markets of the world. The Company has secured global leadership position in Anti-TB and Cephalosporins and has a significant presence in the areas of Cardiovasculars (prils and statins), Diabetology, Asthma and NSAIDs.

The Company's R&D endeavors have resulted in significant progress in its NCE program. The Company's foray into New Drug Delivery Systems has resulted in the development of platform technologies that are being used to develop value-added generic pharmaceuticals.

For the financial year ended March 2008, the Lupin's Revenues and Profit after Tax were Rs.27,730 million (US$ 694 million) and Rs.4,083 million (US$ 102 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, which is among the top six Pharmaceutical companies in India. Through its sales and marketing headquarters in Baltimore, Maryland, Lupin Pharmaceuticals, Inc. is dedicated to delivering high-quality, affordable generic medicines trusted by healthcare professionals and patients across geographies. For more information, visit http://www.lupinpharmaceuticals.com.

Safe Harbor Statement under the U. S. Private Securities Litigation Reform Act of 1995:

This release contains forward-looking statements that involve known and unknown risks, uncertainties and other factors that may cause actual results to be materially different from any future results, performance or achievements expressed or implied by such statements. Many of these risks, uncertainties and other factors include failure of clinical trials, delays in development, registration and product approvals, changes in the competitive environment, increased government control over pricing, fluctuations in the capital and foreign exchange markets and the ability to maintain patent and other intellectual property protection. The information presented in this release represents management's expectations and intentions as of this date. Lupin expressly disavows any obligation to update the information presented in this release.

TOPAMAX(R) is a registered trademark of Ortho-McNeil Neurologics, Inc.

Contact: Edith St-Hilaire

Senior Marketing Manager

410-576-2000 Ext. 207


'/>"/>
SOURCE Lupin Pharmaceuticals, Inc.
Copyright©2008 PR Newswire.
All rights reserved

Related medicine news :

1. Ohio State receives $34M NIH grant
2. IPRO Receives Google Advertising Grant
3. Harvard Medical School receives major NIH grant for galvanizing translational science
4. BUMC, BMC receives Clinical and Translational Science Award from NIH
5. Deane F. Johnson Center Receives Ronald and Nancy Reagan Award
6. OrbusNeich Receives Approval to Market Genous(TM) Bio-engineered R stent(TM) in Taiwan
7. Cornell receives federal grants to create fabrics to render toxic chemicals harmless
8. Einstein-Montefiore Center for AIDS Research receives $8.5M award from NIH
9. Somanetics Receives 510(k) Clearance From the FDA to Expand INVOS System Labeling
10. TriWest Receives National Awards for Innovative Video Communications to Military Community
11. A.S.V., Inc. Receives Safety and Health Award
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/25/2016)... City, Oklahoma (PRWEB) , ... June 25, 2016 ... ... helping both athletes and non-athletes recover from injury. Recently, he has implemented orthobiologic ... the Oklahoma City area —Johnson is one of the first doctors to perform ...
(Date:6/24/2016)... ... 2016 , ... A recent article published June 14 on E ... goes on to state that individuals are now more comfortable seeking to undergo not ... as calf and cheek reduction. The Los Angeles area medical group, Beverly Hills Physicians ...
(Date:6/24/2016)... ... ... Marcy was in a crisis. Her son James, eight, was out of control. Prone to ... , “When something upset him, he couldn’t control his emotions,” remembers Marcy. “If there ... my other children and say he was going to kill them. If we were ...
(Date:6/24/2016)... ... 24, 2016 , ... Dr. Amanda Cheng, an orthodontist ... has extensive experience with all areas of orthodontics, including robotic Suresmile technology, ... , Micro-osteoperforation is a revolutionary adjunct to orthodontic treatment. It can be used ...
(Date:6/24/2016)... , ... June 24, 2016 , ... People across the ... Genome magazine’s Code Talker Award, an essay contest in which patients and their families ... to be presented at the 2016 National Society of Genetic Counselors (NSGC) Annual Education ...
Breaking Medicine News(10 mins):
(Date:6/26/2016)... Story Highlights: ... the health care industry is causing providers to review ... Deloitte offers a suite of solutions for health care ... cost optimization: labor resource analysis, revenue cycle optimization and ... outcomes and better economics ...
(Date:6/24/2016)... Calif. , June 24, 2016  Global ... a biopharmaceutical company developing novel therapeutics for the ... needs, today announced the closing of its previously ... common stock, at the public offering price of ... the offering were offered by GBT. GBT estimates ...
(Date:6/24/2016)... , June 24, 2016 ... the "Structural Electronics 2015-2025: Applications, Technologies, Forecasts" ... In-Mold Electronics, Smart Skin, Structural ... Structural electronics involves electronic and/or ... protective structures, replacing dumb structures such as vehicle ...
Breaking Medicine Technology: