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WASHINGTON - The first generic versions of Zoloft, the top-selling brand-name antidepressant in the United States, received federal approval Friday.– In June 30, 2006–

Israel’s Teva Pharmaceutical Industries Ltd. said it will make generic versions of the drug, also known as sertraline, in 25-, 50-and 100-milligram tablets. Roxane Laboratories Inc., based in Columbus, Ohio, will make a liquid concentrate version of the drug, the Food and Drug Administration said.

In June 30, 2006 The FDA approved today the first generic versions of the antidepressant Zoloft.

The generic drug will come in two forms: You can buy sertraline tablets and a liquid concentrate (sertraline hydrochloride).

“Sertraline tablets are indicated for the treatment of major depressive disorder in adults and the liquid concentrate is approved for the treatment of major depressive disorder and some anxiety-related disorders,” states an FDA news release.

In 2005, Zoloft was the top-selling antidepressant in the U.S., with more than $3 million in U.S. sales, according to the pharmaceutical market research firm IMS Health.

“Generic drugs are safe and effective alternatives to brand-name prescription products and can provide for significant cost savings for the American public,” says Gary J. Buehler, RPh, director of the FDA’s Office of Generic Drug

Drug Interactions

The mechanism of action of sertraline(generic Zoloft) is presumed to be linked to its inhibition of CNS neuronal uptake of serotonin (5HT). Studies at clinically relevant doses in man have demonstrated that sertraline blocks the uptake of serotonin into human platelets. In vitro studies in animals also suggest that sertraline is a potent and selective inhibitor of neuronal serotonin reuptake and has only very weak effects on norepinephrine and dopamine neuronal reuptake. In vitro studies have shown that sertraline has no significant affinity for adrenergic (alpha1, alpha2, beta), cholinergic, GABA, dopaminergic, histaminergic, serotonergic (5HT1A, 5HT1B, 5HT2), or benzodiazepine receptors; antagonism of such receptors has been hypothesized to be associated with various anticholinergic, sedative, and cardiovascular effects for other psychotropic drugs. The chronic administration of sertraline was found in animals to downregulate brain norepinephrine receptors, as has been observed with other clinically effective antidepressants. Sertraline does not inhibit monoamine oxidase.