News
Lupin Receives Final Approval for Lisinopril-HCTZ Tablets
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 $106 million, per IMS Health.
This is Lupin's 16th ANDA approval by the U.S. FDA to date.
About Lupin:
Headquartered in Mumbai, Lupin Ltd. is a leading pharmaceutical company with a strong research focus. It has a program for developing New Chemical Entities. The Company has a state-of-the-art R&D center in Pune. The Company is a leading global player in Anti-TB, Cephalosporins (anti-infectives) and Cardiovascular drugs (ACE inhibitors and Cholesterol-reducing agents) and has a notable presence in the areas of diabetology, anti-inflammatory and respiratory therapy categories.
For the fina ncial year ended March 2006, the Company's Revenues and Profit after Tax were Rs.16,610 million (US$ 375 million) and Rs.1,827 million (US$ 41 million) respectively. Please visit 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 www.lupinpharmaceuticals.com.