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Redhill Biopharma Ltd and IntelGenx Corp receive complete response letter from FDA for RHB-103 oral film for Acute Migraines


Tuesday, 4 Feb 2014 08:00am EST 

RedHill Biopharma Ltd. and together with IntelGenx Corp:Says that they received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding the New Drug Application (NDA) for RHB-103 for the treatment of acute migraines.Says RHB-103 is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1receptor agonist and the active drug in Merck & Co.'s Maxalt.Says a CRL is issued by the FDA's Center for Drug Evaluation and Research to inform companies that certain questions and deficiencies remain that preclude the approval of the application in its present form.Says while continuing to review the FDA's CRL, RedHill and IntelGenx believe that they can supply the requested information based on available data.Says IntelGenx and RedHill further believe that the majority of issues raised by the FDA were recently addressed in an amendment submitted by the companies to the FDA that has yet to be reviewed.Says companies will work with the FDA to address the remaining questions in the CRL and plan to submit the requested information within a few weeks. 

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