FDA approves generic Zoloft drug Sertaline

Sertraline is used medically mainly to treat the symptoms of depression and anxiety. It has also been prescribed for the treatment of obsessive-compulsive disorder, post-traumatic stress disorder, premenstrual dysphoric disorder, panic disorder, and bipolar disorder. It was first approved by the FDA in 1991. The patent for this brand-name drug expired in December 2005. It is anticipated that the generic drug will be available in the United States in June of 2006, manufactured by Andrx, Aurobindo, Genpharm, Ivax, Mylan, and Roxane. In Scandinavia a generic drug called Sertralin, manufactured by HEXAL is available. The price differences between Zoloft and Sertralin are as high as 1.50 dollars per pill.

Sertraline can have a number of adverse effects, including insomnia, asthenia, gastrointestinal complaints, tremors, confusion, dizziness, anorgasmia, and decreased libido; it can induce mania or hypomania in around 0.5% of patients. It has also been known to cause minor weight loss. It is contraindicated in individuals taking MAOIs or undergoing electroconvulsive therapy.

Until 2003 Zoloft was only approved for use in adults ages 18 and over; that year it was approved by the FDA for use in treating children ages 6 to 17 with extreme obsessive compulsive disorder. In June, 2004, Britain banned the use of Zoloft by minors and in February, 2005, Pfizer was forced to change the labeling of Zoloft to include information regarding increased incidences of suicidal behavior and depression in adolescent users of the drug. According to mentalhealth.com, Zoloft is not currently recommended or advised for use in individuals under the age of 18. After these changes, multiple incidences and at least one medical study showed an increased risk of suicide in seniors who were taking Zoloft. In response to these findings, the FDA released a public health warning. This warning indicates that anyone currently using Zoloft for any reason has a greater chance of exhibiting suicidal thoughts or behaviors regardless of age. This warning is questionable, however, due to the types of illnesses Zoloft is used to treat, it is impossible to determine if these tendencies are a side effect of the drug or the illness the drug is meant to treat.

Zoloft has long been seen as the best option for breastfeeding mothers who wish to continue breastfeeding and be able to take their antidepressants. Despite its apparent safety and effectiveness during the breastfeeding period, recent studies and consumer complaints have seen a need to alter Zoloft’s labeling regarding use during the third trimester of pregnancy. Though there are no teratogenetic defects associated with Zoloft, there is reason to be concerned about its effects on infants who were exposed to sertraline during the third trimester in utero. It seems that Zoloft use in late pregnancy significantly increases the potential need for hospitalization and breathing assistance in the newborn period and has also been shown to cause an increased risk of neonatal death. In light of this increased risk it is still being used due to the greater potential risk of a seriously depressed mother to herself and her unborn child. Like all other medications Zoloft’s use must be decided only after carefully weighing out all potential risks and benefits.

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 (See http://www.fda.gov/cder/ogd/generic_competition.htm).

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.

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Tags: bipolar disorder, Britain, depression, director, dizziness, dysphoric disorder, electroconvulsive therapy, fda, FDA's Office of Generic Drugs, food and drug administration, Gary J. Buehler, generic drug applications, insomnia, Ivax, major depressive disorder, mania, Mylan, name prescription products, obsessive compulsive disorder, Office of Generic Drugs, panic disorder, pfizer, post-traumatic stress disorder, retail sales, Scandinavia, Sertaline Sertraline, Sertraline, sertraline hydrochloride, Sertraline tablets, treatment of major depressive disorder, treatment of MDD and some anxiety related disorders, treatment of obsessive-compulsive disorder, tremors, United States, USD, Zoloft, Zoloft tablets

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