Posted by Michael Wonder on 19 May 2018
FDA accepts new drug application submission for Cosmo Pharmaceuticals' rifamycin SV MMX and sets PDUFA date
18 May 2018 - Cosmo Pharmaceuticals today announced that it has been notified by the U.S. FDA that the agency has accepted the filing of its new drug application seeking market approval for rifamycin SV MMX in the United States.
The acceptance of the application reflects the FDA's determination that the application is sufficiently complete to permit a priority review cycle of 6 months, beginning from the filing date, confirming the Prescription Drug User Fee Act date on 16 November 2018 to complete its review.
The FDA stated that their internal mid-cycle review meeting is scheduled on 26 June 2018 and plans to communicate a proposed labelling and, if necessary, any post marketing requirement/commitment requests by 23 August 2018, provided that there are no major deficiencies identified during the review.
