IntelGenx (OTCQX:IGXT) together with RedHill Biopharma (NASDAQ:RDHL) announces that the Ministry of Health of Luxembourg has granted national marketing authorization for RIZAPORT (5 mg and 10 mg), a proprietary oral thin film formulation of rizatriptan benzoate for the treatment of acute migraines.
The national marketing approval in Luxembourg completes the current approval process of RIZAPORT under the European Decentralized Procedure ("DCP"). RIZAPORT is also approved for marketing in Germany and a national Marketing Authorization Application ("MAA") has been submitted in Spain.
Commercialization agreements for RIZAPORT® were signed with Grupo JUSTE S.A.Q.F for Spain and Pharmatronic Co. for South Korea.
RedHill and IntelGenx currently expect to re-submit the RIZAPORT New Drug Application to the FDA in Q3.