Lupin Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted final approval for its Abbreviated New Drug Application (ANDA) for
Lisinopril and Hydrochlorothiazide tablets in 10mg/12.5mg, 20mg/12.5mg and
20mg/25mg strengths.
Lupin's Lisinopril-HCTZ tablets are the AB-rated generic equivalent of
Prinzide(R) Tablets of Merck & Co., Inc. and is indicated for the treatment
of hypertension. The product combines an ACE inhibitor, lisinopril, with a
diuretic, hydrochlorothiazide. Lisinopril-HCTZ is Lupin's first
FDA-approved combination drug.
Total sales for the year ending July 2006 was approximately $106
million, per IMS Health.
This is Lupin's 16th ANDA approval by the U.S. FDA to date.
About Lupin
Headquartered in Mumbai, Lupin Ltd. is a leading pharmaceutical company
with a strong research focus. It has a program for developing New Chemical
Entities. The Company has a state-of-the-art R&D center in Pune. The
Company is a leading global player in Anti-TB, Cephalosporins
(anti-infectives) and Cardiovascular drugs (ACE inhibitors and
Cholesterol-reducing agents) and has a notable presence in the areas of
diabetology, anti-inflammatory and respiratory therapy categories.
For the financial year ended March 2006, the Company's Revenues and
Profit after Tax were Rs.16,610 million (US$ 375 million) and Rs.1,827
million (US$ 41 million) respectively. Please visit
lupinpharmaceuticals 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