Lupin gets USFDA nod for hypertension drug
Lupin Ltd has received approval from USFDA for the company's Abbreviated New Drug Application (ANDA) for Lisinopril - HCTZ Tablets, which is indicated for the treatment of hypertension.
MUMBAI: Lupin Ltd has received approval from USFDA for the company's Abbreviated New Drug Application (ANDA) for Lisinopril - HCTZ Tablets, which is indicated for the treatment of hypertension.
The company informed the Bombay Stock Exchange that it had received the approval for Lisinopril and Hydrochlorothiazide tablets in different strengths of 10mg/12.5mg, 2Omg/12.5mg and 2Omg/25mg.
"The approvals 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," Managing Director of the company Kamal K Sharma said.
Lisinopril - HCTZ tablets are being marketed by Merck & Co Inc under the brand name 'Prinzide' and their total sales for the year ending July 2006 were approximately $106 million, as per IMS Health.
Lisinopril - HCTZ is Lupin's first FDA approved combination drug and following this approval the company has 16 approved ANDAs, it said.
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