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June 30, 2006 -- The FDA approved today the first generic versions of the antidepressant Zoloft.
The generic drug will come in two forms: 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 Drugs, in an FDA news release. "Our office is committed to increasing the number of approved generic alternatives as quickly as possible," Buehler says.
Zoloft is made by the drug company Pfizer. Generic sertraline tablets are made by Ivax Pharmaceuticals. Generic sertraline hydrochloride oral concentrate is made by Roxane Laboratories. Pfizer is a WebMD sponsor.
SOURCES: News release, FDA. IMS Health: "Commonly Requested Therapeutic Class and Product Information (update February 2006)."