Patent for Antidepressant Zoloft Expired June 30
Competition from generic copies of the formerly patented drug will bring prices for the medication down sharply. As a rule of thumb, analysts agree, the price of a drug that loses its patent tends to drop 80 percent within the next year.
As tested in the FDA approval process, a generic drug is a copy that must have the same active ingredients as the brand name drug and be the same “in dosage, safety, and strength, how it is taken, quality, performance, and intended use.” But by trademark law it must not look identical to the branded drug; and colors, flavors, and certain other inactive ingredients may be different.
FDA Approves First Drug for Seasonal Depression
On June 12 the FDA announced its approval of a new prescription drug, Wellbutrin XL, “for prevention of major depressive episodes in patients with a history of seasonal affective disorder (SAD),” or winter blues.
About six percent of American adults, and a much higher proportion of Chronic Fatigue Syndrome and Fibromyalgia patients, suffer the ravages of depression as the hours of daylight draw in during autumn and winter.
The FDA approval is based on the results of three placebo-controlled trials in adults with a history of SAD. These involved treatment initiated in the fall before the onset of symptoms and continuing through the end of March. Comparing results for the patients treated with Wellbutrin XL versus those receiving a placebo, they found that a “significantly higher” percentage of the Wellbutrin XL recipients were depression-free at the end of treatment (84 percent vs. 72 percent).
Important side effects “to watch for with Wellbutrin XL, especially shortly after the initiation of the treatment, include agitation, anxiety, and insomnia,” the FDA report states.
For more information, go to FDA News at http://www.fda.gov/bbs/topics/NEWS/2006/NEW01388.html