понедельник, 18 апреля 2011 г.

Lupin Pharmaceuticals Announces Tentative Approval Of Generic ZOLOFT(R)

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(R) 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.



About Lupin



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 lupinworld 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
lupinpharmaceuticals.



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.


Lupin Pharmaceuticals, Inc.

lupinpharmaceuticals

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