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FDA Approves First Generic Sertraline

By Pharmaceutical Processing | July 19, 2006

As part of the FDA’s on-going efforts to increase the available generic drug alternatives for American consumers, the agency recently approved the first generic version of Zoloft tablets (sertraline), as well as a liquid concentrate (sertraline hydrochloride) version of the product.

Sertraline tablets are indicated for the treatment of major depressive disorder (MDD) in adults and the liquid concentrate is approved for the treatment of MDD and some anxiety related disorders. In 2005, Zoloft was the sixth highest-selling brand-name drug in the United States, with retail sales totaling $2,561,069,000.

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

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