FDA Approves First Generic Sertraline

As part of the Food and Drug Administration's (FDA) on-going efforts to increase the available generic drug alternatives for American consumers, the agency today 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."

The economic benefits of FDA's generic drug approval program are significant because generics can cost a fraction of the price of the brand name drugs and generic drugs 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 that are safe and effective alternatives may quickly lead to reductions in spending. The savings would likely increase as more competitors enter the market.

FDA's Office of Generic Drugs (OGD) continues working expeditiously to review and take action on generic drug applications. For more information on other first generic versions, please see http://www.fda.gov/cder/ogd/approvals/1stgen0506.htm.

For additional information related to FDA's Office of Generic Drugs, please go to: http://www.fda.gov/cder/consumerinfo/generic_equivalence.htm.

The oral concentrate is manufactured by Roxane Laboratories, Inc and tablets are manufactured by IVAX Pharmaceuticals.

Source: FDA Approves First Generic Sertraline

Posted: June 2006


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