KV Pharmaceutical Company has received approval from the US Food and Drug Administration to market six strengths of Diltiazem HCl ER capsules (AB rated to Tiazac from Forest Pharmaceuticals, Inc) through its wholly-owned generic non-branded subsidiary, ETHEX Corporation. ETHEX will begin shipments of all six strengths immediately.
The launch of the six strengths of Diltiazem (120mg, 180mg, 240mg, 300mg, 360mg and 420mg) will complement ETHEX's highly regarded cardiovascular family of products and will make KV the first generic company that will have a full line of product AB-rated to Tiazac. KV also believes it is the first generic company to receive approval of the 420mg strength dosage, and thus expects to have six months exclusivity on this strength. However, it is also expected that the brand manufacturer may launch an "authorized generic" version. Total market sales for this product are approximately $ 160 million. Tiazac is indicated for the treatment of hypertension (high blood pressure) and angina (chest pain).
Tiazac belongs to a class of drugs known as calcium channel blockers (CCBs) that lower blood pressure by blocking calcium influx into the smooth muscle cells of the blood vessels. CCBs may be used to treat high blood pressure, angina and some arrhythmias. Approximately 50 million people in the US have hypertension, however, approximately 52 per cent are not on therapy and only 21 per cent are on adequate control, which controls their hypertension. Hypertension is a lifelong condition and can remain asymptomatic for many years. It is very important to reach one's blood pressure goal and maintain that goal throughout one's life.
Marc S. Hermelin, vice chairman of the board and CEO stated, "We are delighted to be extending ETHEX's cardiovascular expertise into the CCB segment with a complete line of AB-rated equivalents to an outstanding product like Tiazac. The approval extends ETHEX's line-up of quality ANDA products across multiple therapeutic categories, with several more important opportunities in our pipeline. We are pleased to be able to offer a full line of this important product to our customers and patients."