ANDA approvals take several months. And in this case, all the generic applications had to be amended per FDA request. I’d rather not go into detail. One has been revised and submitted, the two others are still in the revision process pending additional information from excipients and API manufacturers. When the FDA notifies you that revisions are required, you are put back to the bottom of the pile of all the other generic drug applications. It will take some time, but they will get approved but it's very unlikely to happen in 2009.
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