Lupin gets US FDA approval for Lisinopril-HCTZ Tablets

Lupin Ltd has announced that the US FDA has approved the Company’s Abbreviated New Drug Application (ANDA) for its Lisinopril and Hydrochlorothiazide Tablets (Lisinopril-HCTZ Tablets) in 10mg / 12.5mg, 2Omg / 12.5mg and 2Omg / 25mg strengths. Lisinopril - HCTZ Tablets are indicated for the treatment of hypertension.

Lisinopril-HCTZ Tablets are being marketed by Merck & Co. Inc. under the brand name Prinzide. The total sales for the year ending July 2006 were approximately U$ 106 million, per IMS Health.

"The approval of Lisinopril-HCTZ Tablets expands the breadth of the cardiovascular offering of the Company and is a value-add follow on to our earlier launch of Lisinopril Tablets," said Dr. Kamal K Sharma, Managing Director of the Company.

Lisinopril-HCTZ is the Company’s first FDA approved combination drug and with this approval, the Company now has 16 approved ANDAs.

Source : Equity Bulls

Keywords