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, 20mg/12.5mg and 20mg/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, as 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, a company press release said.