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An FDA approval for a new indication can be obtained in less than 18 months, compared to the eight years it takes to bring a drug from the lab to the pharmacy. On April 16, 2001, the FDA approved Paxil, manufactured by the now-called GlaxoSmithKline (GSK) for the new indication of GAD. “The FDA considers a DSM notation sufficient proof that a disease actually exists and, unlike new drugs, existing pharmaceuticals don’t require an exhaustive round of clinical studies.”