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The submission was granted a Priority review status and a PDUFA goal date of June 5, 2012. In April 2012, the company was notified by the Agency that additional review time would be required, prompting a 3 month extension to the PDUFA date, which was reset to September 5, 2012. On September 5, the company issued a release indicating that the NDA was still under review and that final action had not been taken by the Agency: "By taking no action at this time, the FDA has allowed for the currently ongoing dialogue between Salix and the FDA to continueThe primary topic is the production and control of the crofelemer active pharmaceutical ingredient, a complex mixture that is the first botanical product to be reviewed by the Agency for oral use.
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