New Prozac Rival Gets FDA Nod

Bristol-Myers Squibb Co. said Thursday that it has received approval from the Food and Drug Administration to sell a new antidepressant, Serzone, which will be in pharmacies within a few weeks. The company said the drug differs from other antidepressants both chemically and in the way it operates. It also has fewer and less severe side effects--such as tremors, agitation and sexual dysfunction--than some other products used in treating depression, Bristol-Myers said, adding that many patients treated with Serzone responded favorably within several weeks.

The world’s leading antidepressant is Prozac, the first of a class of drugs called selective serotonin re-uptake inhibitors, which boost the brain levels of serotonin, a regulator of moods. An older class of antidepressant, called tricyclics, blocks serotonin receptors in the brain. Serzone is the first drug to do both, said Dr. Jan Fawcett, psychiatry chairman at Rush Presbyterian-St. Luke’s Medical Center in Chicago.

To promote Serzone, Bristol-Myers said, it is undercutting competitors’ prices, introducing the drug at 10% to 20% below the average wholesale price of competitive products.

Depression is the nation’s most prevalent mental health problem, afflicting about 15 million Americans at some point in their lives and costing an estimated $44 billion a year in medical bills and lost productivity. Americans spend about $3 billion a year on drugs to battle it.

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