FDA Approves First Generic Sertraline Tablets for Treatment of Major Depressive Disorder

The United States Food and Drug Administration approved generic sertraline (Zoloft, Pfizer) for the treatment of major depressive disorder (MDD) in adults. The FDA also approved a liquid concentrate, sertraline hydrochloride, for the treatment of MDD and specified anxiety-related disorders.

In a news release, Gary J. Buehler, Director of the FDA’s Office of Generic Drugs, stated his office’s commitment to “increasing the number of approved generic alternatives as quickly as possible.”

Brand-name sertraline is approved for treatment of depression, SAD, PTSD, panic disorder, OCD, and premenstrual dysphoric disorder. Brand-name sertraline comes in 25-mg, 50-mg, and 100-mg doses, and the most common side effects are dry mouth, insomnia, nausea, diarrhea, and sleepiness. Sertraline should not be co-prescribed with MAOIs. http://www.fda.gov/bbs/topics/NEWS/2006/NEW01404