FDA APPROVES SIX STRENGTHS OF KV PHARMA'S DILTIAZEM

KV Pharmaceutical has received approval from the FDA to market six strengths of extended-release diltiazem HCl capsules, an AB-rated generic of Forest Laboratories' Tiazac, through its wholly owned generic subsidiary, ETHEX.

KV believes it is the first generic company to receive approval of the 420-mg dosage and expects to have six months of marketing exclusivity for this strength. However, the company also expects that the brand manufacturer may launch an authorized generic version of the drug. Total market sales for this product are approximately $160 million, according to KV.

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.