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FDA approves first generic for Sertraline

Aug 5, 2006 - 6:58:00 PM

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Last week the Food and Drug Administration, as part of its on-going efforts to increase available generic drug alternatives for Americans, approved the first generic version of Zoloft tablets (sertraline), as well as a liquid concentrate (sertraline hydrochloride) version of the drug.

Sertraline is indicated for the treatment of major depressive disorder (MDD) in men and women and the liquid concentrate is approved to treat MDD and some anxiety-related disorders. Last year, Zoloft was the sixth highest-selling brand-name drug in the United States, with retail sales of over $2 billion.

Gary J. Buehler, Director of the Office of Generic Drugs, called generic drugs “safe and effective alternatives to brand name prescription products,” and said thy can provide significant cost savings for the public. He went on to say, “Our office is committed to increasing the number of approved generic alternatives as quickly as possible.”

There are significant benefits to be found with the FDA’s generic drug approval program because generic drugs can cost a fraction of the price of the brand name versions, and generics represent about two-thirds of total prescription doses sold in the United States in 2004, according to IMS data on U.S. retail sales. Competition from generic drugs may soon lead to reductions in spending, with the savings likely increasing as more and more competitors enter the market.

© Copyright 2007 Insight Journal Online Magazine.

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FDA Press Release (Sertraline/Zoloft Generic)
Zoloft Fact Sheet
Zoloft Home Page

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