Lupin gets US-FDA nod for Lisinopril-HCTZ Tablets

Mumbai, Sep 28 (UNI) Lupin today announced that the US FDA has approved the company's Abbreviated New Drug Application (ANDA) for its Lisinopril and Hydrochlorothiazide Tablets used for the treatment of hypertension.

Announcing this to BSE, the company said Lisinopril-HCTZ Tablets cleared by United States Food and Drug Administration (USFDA) are in the range of 10mg / 12.5mg, 2Omg / 12.5mg and 2Omg / 25mg strengths.

Lisinopril-HCTZ Tablets are being marketed by Merck&Co under the brand name Prinzide. The total sales for the year ending July 2006 was approximately USD 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 Managing Director Dr Kamal K Sharma.

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

UNI SN GB SKB1851