Drug firm Zydus Cadila Wednesday said it has received final approval from the US health regulator to market Triamterene and Hydrochlorothiazide capsules, indicated to treat high blood pressure.
The company has received approval from the US Food and Drug Administration (USFDA) to market the drug in the strength of 37.5 mg/25 mg, Zydus Cadila said in a BSE filing.
The company said it will manufacture the drug at the group's manufacturing facility at special economic zone (SEZ), Ahmedabad.
Zydus Cadila said the fixed dose combination of Triamterene and Hydrochlorothiazide is indicated for the treatment of hypertension or edema in patients who have developed hypokalemia (low serum potassium levels) on Hydrochlorothiazide alone.
This medication may be used alone or as an adjunct to other antihypertensive drugs.
The company has more than 249 approvals and has so far filed over 350 abbreviated new drug applications (ANDAs) since it commenced filings in 2003-04.
Shares of the company's listed entity Cadila Healthcare were trading 0.17 per cent down at Rs 318.25 apiece on the BSE.