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RedHill, IntelGenx Receive CRL for RHB-103

Relates to third party CMC and packaging and labeling of the product

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By: Kristin Brooks

Managing Editor, Contract Pharma

RedHill Biopharma Ltd. and IntelGenx Corp. have received a Complete Response Letter (CRL) from the FDA regarding the NDA for RHB-103 for the treatment of acute migraines. RHB-103 is an oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck’s Maxalt. The questions raised in the CRL for RHB-103 primarily relate to third party Chemistry, Manufacturing and Controls (CMC) and to the packaging and labeling of the product. There were no questions or de...

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