Ahmedabad-based drug major Zydus Cadila today said that it has received approval from the US Food and Drug Administration (USFDA) to market two anti-hypertension drugs in the US market. These include Losartan Potassium tablets and Losartan Potassium plus Hydrochorothiazide tablets.
The company has approval to market Losartan Potassium tablets in the denominations of 25 mg, 50mg, and 100mg, while it can sell the Lostartan plus Hydrochorothiazide tablets in denominations of 50/12.5mg and 100/25 mg. Zydus has already launched both the products in the US market post approval from the health regulator.
As par NDC Health, sales of Losartan Potassium tablets in the US market is estimated at $1.3 billion and that of Losartan Potassium plus Hydrochlorothiazide tablets is estimated at $944 million in 2010.
The Ahmedabad-based pharma major had launched Tamsulosin capsules (0.4mg) in the US in April.
Following this approval, the group has now approvals for 56 products for the US market and has so far filed 113 abbreviated new drug application (ANDA) since the commencement of filing process in the fiscal 2003-04 fiscal.
Zydus launched the anti-hypertensive drugs in the US market on the same day that it received the approval. It had done the same in case of Tasulosin capsules earlier this year. Apart from these two, the Group has had three more first day launches in the US market in 2008-09.