Lupin Receives Final Approval for Lisinopril-HCTZ Tablets.
Mumbai, 28 September 2006:
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® 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 $106 million, per IMS Health.
This is Lupin's 16th ANDA approval by the US FDA to date.
Headquartered in Mumbai, Lupin Ltd. is a leading pharmaceutical company with strong
research focus. It has a programme for developing New Chemical Entities. The
Company has state-of-the-art R&D center in Pune. The Company is a leading global
player in Anti-TB, Cephalosporins (anti-infectives) and Cardiovascular drugs (prils and
statins) and has a notable presence in the areas of diabetology, NSAIDS and Asthma.
For the financial year ended March 2006, the Company's Revenues and
Profit after Tax were Rs.16,610 million (US$ 375 million) and
Rs.1,827 million (US$ 41 million) respectively.
For further information contact: Edith St-Hilaire
LUPIN PHARMACEUTICALS, INC.
Phone: (410) 576-2000
Fax : (410) 576-2221
E-mail : email@example.com