This is a relief for the drugmaker, which faced repeated setbacks in gaining agency approval and needs to replace revenue that will be lost when patents on Effexor XR - a $3.8 billion moneymaker - start to expire this year. The next big hurdle for the drugmaker is winning FDA approval to market Pristiq to treat hot flashes caused by menopause. As with the indication for depression, Wyeth has faced repeated delays at the agency and it remains unclear how this will play out.
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