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anxiety disorders, panic disorder, obsessive-compulsive disorder, phobias, post-traumatic stress disorder |
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FDA approves first generic sertraline (Zoloft®)
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As part of the Food and Drug Administration's (FDA) efforts to increase generic drug alternatives, the agency today approved the first generic version of Zoloft® tablets (sertraline), as well as a liquid concentrate (sertraline hydrochloride) version of the product. The oral concentrate is manufactured by Roxane Laboratories, Inc and the tablets by IVAX Pharmaceuticals. 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." posted Saturday, 1 July 2006 |