This site is intended for healthcare professionals
Drug news

FDA issues Complete Response Letter for RB 103 for Migraine-RedHill BioPharma

Read time: 1 mins
Last updated:11th Feb 2014
Published:11th Feb 2014
Source: Pharmawand

RedHill Biopharma Ltd. an Israeli biopharmaceutical company together with IntelGenx Corp., a Canadian drug delivery company have announced that they received a Complete Response Letter (CRL) from the FDA regarding the New Drug Application (NDA) for RHB-103 for the treatment of acute Migraines. RHB-103 is a proprietary oral thin film formulation of rizatriptan benzoate, a 5-HT1 receptor agonist and the active drug in Merck & Co.�s Maxalt.

The questions raised by the FDA in the CRL regarding the NDA for RHB-103 primarily relate to third party Chemistry, Manufacturing and Controls and to the packaging and labeling of the product. No questions or deficiencies were raised relating to the product's safety and the FDA�s CRL does not require additional clinical studies. While continuing to review the FDA�s CRL, RedHill and IntelGenx believe that they can supply the requested information based on available data.

Learning Zones

The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.