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Nov. 9, 2015, 8:31 AM
- RedHill Biopharma (NASDAQ:RDHL) and development partner IntelGenx (OTCQX:IGXT) announce that RIZAPORT (RHB-103) has been cleared for sale by the German Federal Institute for Drugs and Medical Devices for the treatment of acute migraines. The national approval of RIZAPORT in Germany was granted under the European Decentralized Procedure in which Germany was the Reference Member State. Clearance in Luxembourg, the Concerned Member State, should happen shortly. Other EU countries have the option of accepting Germany's marketing authorization without requiring a separate application process.
- RIZAPORT, 5 mg and 10 mg, is an oral thin film formulation of rizatriptan benzoate that is the first oral thin film bioequivalent to Merck GmbH's Maxalt Lingua. It is a therapeutic option for patients suffering from dysphagia (difficulty swallowing) and those suffering from migraine-related nausea, which may be 80% of the total migraine population. About 2M Europeans are prone to daily migraine attacks.
- The companies submitted a New Drug Application (NDA) to the U.S. FDA in 2013 but received a Complete Response Letter (CRL) in 2014 citing issues related to CMC (Chemistry, Manufacturing and Controls), which the firms are working to address, including a compliant source of raw material.
- RDHL is up 4% premarket on light volume.
IntelGenx, through its cutting edge formulation platforms, has developed a broad and diverse product portfolio, including products for the treatment of indications such as severe depression, hypertension, erectile dysfunction, migraine, insomnia, CNS indications, idiopathic pulmonary fibrosis,... More
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