Lupin Pharmaceuticals, Inc. Announces Tentative Approval Of Generic ZOLOFT(R)
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- Published on Wednesday, 03 January 2007 02:00
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BALTIMORE, MD, USA | Jan 02, 2006 | Lupin Pharmaceuticals, Inc. announced that the U.S. Food and Drug Administration (FDA) has granted tentative approval for the Company's Abbreviated New Drug Application (ANDA) for Sertraline Hydrochloride Tablets, 25mg, 50mg and 100mg. Final approval is expected upon the expiration of the first ANDA filer's 180-day marketing exclusivity in February 2007.
Upon final approval, Lupin's Sertraline Tablets will be the AB-rated generic equivalent of Pfizer's ZOLOFT® Tablets, indicated for the treatment of major depressive disorder. The brand product had annual sales of approximately $3.1 billion for the twelve months ended July 2006, based on IMS sales data.
Headquartered in Mumbai, Lupin Ltd. is a leading pharmaceutical company with a strong research focus. It has a program for developing New Chemical Entities. The Company has a state-of-the-art R&D center in Pune. The Company is a leading global player in Anti-TB, Cephalosporins (anti-infectives) and Cardiovascular drugs (prils and statins) and has a notable presence in the areas of diabetology, NSAIDs and Asthma.
For the half-year ended September 2006, the Company's Revenues and Profit after Tax were Rs.9,917 million (US$220 million) and Rs.1,090 million (US$24 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 five 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.
*ZOLOFT® is a registered trademark of Pfizer Pharmaceuticals.
For More Information: Contact: Edith St-Hilaire Senior Marketing Manager 410-576-2000
SOURCE: Lupin Pharmaceuticals, Inc.