FDA Year-End Approval Spate As Expected

The US Food and Drug Administration continued its tradition ofapproving a flurry of new products at the end of the year in order to meet its approval goals. The more notable examples amongst this year's catch include new antibiotics, the second angiotensin II receptor antagonist for hypertension, a new treatment for multiple sclerosis and drugs for canker sores and hyperprolactinemia.

1st Losartan Competitor Ciba (now Novartis) has received US marketing clearance for Diovan (valsartan), the latest entry in a novel class of antihypertensive drugs, the angiotensin II receptor inhibitors. It was first launched in July 1996 in Germany, and is the second drug in this class to reach the market after Merck & Co's Cozaar (losartan), which debuted in 1994.

Valsartan is indicated for the first-line treatment of hypertension, and offers blood pressure control comparable to current leading antihypertensive therapies (lisinopril and enalapril) and an outstanding side-effect profile, according to Ciba.