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Apotex Corp. filed for an injunction against GlaxoSmithKline and the FDA for the removal of six of the manufacturer’s Paxil patents from the agency’s Orange Book. Apotex said the listing of these additional patents indefinitely delays Apotex’s own launch of paroxetine hydrochloride. “GlaxoSmithKline is manipulating the patent system and the provisions of the Food, Drug and Cosmetic Act in order to block the marketing of a less costly generic version of Paxil,” said Tammy McIntire, president of Apotex.
Just as the patent is about to run out for Prozac, we learn that this worldwide topselling antidepressant isn’t any more effective than its competitors, Paxil and Zoloft. These three popular antidepressants, all from the same drug class, called selective serotonin reuptake inhibitors (SSRIs), were shown to be of similar effectiveness in a new study published in the Journal of the American Medical Association (JAMA, 12/19/01).
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A team of researchers led by Kurt Kroenke, MD, of the Regenstrief Institute for Health Care in Indianapolis, made a point of recruiting study participants treated by their primary care physicians, as this is the most common route to an antidepressant prescription. The 573 depressed adult participants were randomly assigned to receive Prozac, Paxil, or Zoloft for nine months.
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