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news.Forest Laboratories and Cypress Bioscience have reported that the FDA has accepted for review the new drug application for milnacipran for the treatment of fibromyalgia.
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With a standard 10-month review timeline, the FDA Prescription Drug User Fee Act target action date is expected to occur by the end of October 2008.
The FDA has advised that they are moving toward class labeling for drugs used to treat fibromyalgia, with any distinctions among therapies reflected in specific product labels instead of differences in the approved indications.