Lannett Company, Inc., a company that develops, manufactures, packages, markets and distributes generic pharmaceutical products for a wide range of indications, has received marketing approval from the US Food and Drug Administration (FDA) of its Abbreviated New Drug Application (ANDA) for triamterene with hydrochlorothiazide 37.5/25mg capsules. Triamterene with hydrochlorothiazide 37.5/25mg capsules is therapeutically equivalent to the reference listed drug, Dyazide capsules, 25/37.5mg, of SmithKline Beecham.
Sales of triamterene hydrochlorothiazide 37.5/25mg capsules, at Average Wholesale Price (AWP) were approximately $111 million for the 12 months ending October 2011, according to Wolters Kluwer.
Triamterene/hydrochlorothiazide is a combination antihypertensive drug with a potassium-sparing diuretic (triamterene) and a thiazide diuretic (hydrochlorothiazide). It works by making the kidneys eliminate sodium and water from the body, which helps to lower blood pressure. The triamterene component helps minimize potassium loss.
“This afternoon we began shipping triamterene with hydrochlorothiazide capsules, an important medication for which there have been recent shortages in the marketplace,” said Arthur P. Bedrosian, president and chief executive officer of Lannett. “We have been working with various departments within the FDA, and commend their quick actions, to alleviate the shortage.”
Bedrosian also noted that the company expects the addition of triamterene with hydrochlorothiazide capsules will be an important catalyst for sales and earnings growth.